Category: Paediatrics

Categories : Paediatrics VaccinesTags :

Sanofi Receives Registration for Beyfortus® in SA to Protect Infants Against RSV

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Photo by Elen Sher on Unsplash

Sanofi is pleased to share that the South African Health Products Regulatory Authority (SAHPRA) has granted registration for Beyfortus® (nirsevimab), a long-acting monoclonal antibody designed to protect infants against Respiratory Syncytial Virus (RSV).

Beyfortus® is the first long-acting monoclonal antibody designed to provide protection across the RSV season for all infants, including those born at term, preterm, or with underlying conditions. It is given as a single intramuscular dose just before or during the RSV season¹ and is expected to be available before the 2026 RSV season.

RSV is one of the leading causes of Lower Respiratory Tract Infections (LRTIs) such as bronchiolitis and pneumonia in young children, and a major driver of hospitalisation in infants under one year of age.3 Globally, RSV is responsible for 20 to 40% of pneumonia and 40 to 80% of bronchiolitis hospitalised cases among infants under one year of age.2

It was estimated that in a year, RSV caused around 33 million acute lower respiratory infections in children younger than five years, resulting in 3,6 million hospitalisations and over 100 000 RSV-attributable deaths globally3. RSV-related medical costs in this age group are estimated at €4.82 billion per year, including hospital, outpatient, and follow-up care7.

In South Africa, RSV infections occur year-round with a strong seasonality from February to May4. Each year in South Africa, there are approximately 96 000 cases of RSV severe acute respiratory illnesses in children under five years of age, and among newborns under one month, about one in seven requires admission for severe RSV9. The incidence and severity of RSV LRTI are highest in infants under 6 months of age, representing 22% of all-cause hospital admissions in this age group. 41% of the LRTI-related hospitalisations are attributable to RSV.5 

RSV infections also have long lasting consequences as a first episode of RSV LRTI is associated with an increased risk of subsequent LRTIs. In addition, RSV is associated with recurrent wheezing in early childhood.6

Though risk factors such as prematurity and underlying conditions will increase the probability and severity of RSV infections in children, the majority of severe RSV outcomes occur in healthy full‑term infants. They represent the majority of ICU admissions (65.8%) and mechanical ventilation cases (59.8%) among RSV‑infected infants, and globally, healthy infants account for around 57% of RSV‑related deaths.10-11 For this reason, all infants are at risk of RSV disease. 

A single dose of Beyfortus® provides immediate and season-long protection, lasting for at least five months, corresponding to a typical RSV season¹. In the MELODY phase III trial*, nirsevimab reduced medically attended RSV-LRTI by 74.5% and hospitalisations by 62.1% compared with placebo,8 while the HARMONIE real-world study found an 82.7% reduction in RSV-related hospitalisations through 180 days after immunisation14. Beyfortus® demonstrated a consistent safety profile across term, preterm, and high-risk infants, with the most common adverse reactions being mild rash (0.7%), fever (0.5%), and injection-site reactions (0.3%)¹.

Beyfortus® has also demonstrated its strong public health impact in real-world settings. Following its introduction in 2024 in Chile and in 2023 in Galicia, Spain, the effectiveness of Beyfortus® against RSV-related LRTI hospitalisations was estimated to be 76.4% and 85.9%, respectively. In Chile, Beyfortus® demonstrated 49.7% effectiveness against all-cause hospitalisation. 12-13

“RSV causes a great burden on families and the healthcare systems in South Africa and worldwide,” says Diane Buron, South Africa Medical Head for Sanofi Vaccines. “It is a leading cause of infant hospitalisation during the season and Beyfortus® has the potential to change that. With only one dose, babies will be effectively protected throughout the season and thousands of cases and hospitalisations can be averted.”

“Because the majority of RSV cases are in term and healthy infants,” says Buron “proposing this innovative and effective protection to all infants will have a significant impact on the families and healthcare system.”

More than 6 million infants worldwide have now received Beyfortus®, supported by over 40 real-world studies across four continents, in both the Northern and Southern hemispheres. The introduction of Beyfortus® in South Africa is a significant advancement in paediatric respiratory protection and supports the global goal of reducing preventable infant morbidity and mortality linked to RSV8.

*The Phase 3 MELODY trial was a randomised, double-blind, placebo-controlled trial conducted across 21 countries designed to determine the safety and efficacy of Beyfortus®  against medically attended LRTD caused by RSV in healthy term and late preterm infants (35 weeks gestational age or greater) entering their first RSV season, including efficacy against severe disease such as hospitalisation, through 150 days after dosing. The primary endpoint was met, reducing the incidence of medically attended RSV LRTD by 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo. The efficacy of Beyfortus® against the secondary endpoint of hospitalization was 62.1% (-8.6, 86.8). A pre-specified pooled analysis of the Phase 3 MELODY trial showed the efficacy of Beyfortus® against medically attended RSV LRTD and medically attended RSV LRTD with hospitalisation was 79.5% (95% CI 65.9, 87.7; P<0.0001) and 77.3% (95% CI 50.3, 89.7; P<0.001), respectively.

References

1. Sanofi-Aventis South Africa (Pty) Ltd. Beyfortus®  Professional Information (PI). Version E, 2025-09-18.
2. Dangor et al. (2023) – Bronchiolitis v. bronchopneumonia: Navigating antibiotic use within the lower respiratory tract infection spectrum. S Afr Med J 113(6):e709

3. Li Y et al. Global, regional, and national disease burden estimates of acute lower-respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022; 399: 92047–64.
4. National Institute for Communicable Diseases (NICD). Respiratory Syncytial Virus (RSV). Available at: https://www.nicd.ac.za/diseases-a-z-index/respiratory-syncytial-virus-rsv/ (Accessed January 2026).
5. Wedderburn CJ et al. Risk and rates of hospitalisation in young children: A prospective study of a South African birth cohort. PLOS Glob Public Health. 2024

6. Zar HJ et al. Early-life respiratory syncytial virus lower respiratory tract infection in a South African birth cohort: epidemiology and effect on lung health. Lancet Glob Health. 2020.
7. Zhang S et al. Cost of respiratory syncytial virus-associated acute lower-respiratory infection management in young children at the regional and global level: a systematic review and meta-analysis. J Infect Dis. 2020; 222(Suppl 7): S680–S687.
8. Hammitt LL et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med. 2022; 386(9): 837–846.

9. Moyes J et al. The burden of RSV-associated illness in children aged < 5 years, South Africa, 2011 to 2016. BMC Med 21, 139 (2023).

10. Nair H, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010;375:1545–1555.
11. Li Y, et al. Global, regional, and national disease burden estimates of RSV-associated acute lower respiratory infection in young children in 2019: a systematic analysis. Lancet. 2022;399:2047–2064

12. Razzini JL. Impact of universal nirsevimab prophylaxis in infants on hospital and primary care outcomes across two respiratory syncytial virus seasons in Galicia, Spain (NIRSE-GAL): a population-based prospective observational study. Lancet Infect Dis. 2026

13. Torres JP et al. Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL): a retrospective observational study. Lancet Infect Dis. 2025 Nov;25(11):1189-1198.

14. Munro et al. 180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial. Lancet Child Adolesc Health. 2025 Jun;9(6):404-412.

Categories : Metabolic Disorders PaediatricsTags :

UK Study Proves Effectiveness of Childhood Type 1 Diabetes Screening

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Photo by Pavel Danilyuk

Thousands of families have taken part in a landmark UK study led by researchers at the University of Birmingham which shows that childhood screening for type 1 diabetes is effective, laying the groundwork for a UK-wide childhood screening programme.

Results from the first phase of the ELSA (Early Surveillance for Autoimmune diabetes) study, co-funded by charities Diabetes UK and Breakthrough T1D, have been published in a research letter in The Lancet Diabetes & Endocrinology today.

The findings mark a major step towards a future in which type 1 diabetes can be detected in children before symptoms appear. Currently, over a quarter of children aren’t diagnosed with type 1 diabetes until they are in diabetic ketoacidosis (DKA), a potentially fatal condition that requires urgent hospital treatment. Early detection can dramatically reduce emergency diagnoses and could give children access to new immunotherapy treatments that can delay the need for insulin for years.

We are working towards a future where type 1 diabetes can be detected in a timely manner

Professor Parth Narendran, lead researcher

Launched in 2022, ELSA is the first UK study of its kind, tested blood samples from 17,931 children aged 3-13 for autoantibodies, markers of type 1 diabetes that can appear years before symptoms.

Children without autoantibodies are unlikely to develop type 1 diabetes, while those with one autoantibody have a 15% chance of developing the condition within 10 years. Having two or more autoantibodies indicates the immune system has already started attacking the insulin-producing cells in the pancreas and it is almost certain these children will eventually need insulin therapy. This is known as early-stage type 1 diabetes.

Among the 17,283 children aged 3-13 years who were screened for type 1 diabetes risk at the time of analysis:

  • 75 had one autoantibody, signaling increased future risk.
  • 160 had two or more autoantibodies but did not yet require insulin therapy, indicating early-stage type 1 diabetes.
  • 7 were found to have undiagnosed type 1 diabetes with all needing to start insulin immediately.

Lead researcher, Parth Narendran, Professor of Diabetes Medicine at the University of Birmingham, said: “We are extremely grateful to all the families who have participated in the study and generously given their time to help understand how a UK-wide screening programme could be developed. Together with Diabetes UK, Breakthrough T1D and the National Institute for Health and Care Research, we are working towards a future where type 1 diabetes can be detected in a timely manner, and families appropriately supported and treated with medicines to delay the need for insulin.

“We are also grateful to partners across the Birmingham Health and Life Sciences District and beyond as well as the NIHR for the support they have provided in getting us to where we are.”

Interventions before diagnosis

Families of children found to have early-stage type 1 diabetes received tailored education and ongoing support to prepare for the eventual onset of type 1 diabetes symptoms and to ensure insulin therapy can begin promptly when needed, reducing the chances of needing emergency treatment. Those with one autoantibody also received ongoing support and monitoring.

Some families were also offered teplizumab, the first ever immunotherapy for type 1 diabetes, which can delay the need for insulin by around three years in people with early-stage type 1 diabetes. The first patient was treated at Birmingham Children’s Hospital. Teplizumab was licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK in August 2025, and is currently being assessed by the National Institute for Health and Care Excellence (NICE) to determine whether it should be available through the NHS.

As of November 2025, more than 37,000 families have signed up to the ELSA programme. Building on this strong foundation, the second phase of the research, ELSA 2, launches today. ELSA 2 will expand screening to all children in the UK aged 2-17 years, with a focus on younger children (2-3 years) and older teenagers (14-17 years). The research team aims to recruit 30,000 additional children across these new age groups.

ELSA 2 will also establish new NHS Early-Stage Type 1 Diabetes Clinics, providing families taking part with clinical and psychological support and creating a clear pathway from screening to diagnosis, monitoring and treatment.

Case study: Knowing what’s coming … has made an enormous difference

Amy Norman, 44, from the West Midlands, was diagnosed with type 1 diabetes at the age of 13. She recently discovered via the ELSA study that her 11-year-old daughter, Imogen, is in the early stages of type 1 diabetes but has been able to slow its progression as the second child in the UK to access a breakthrough immunotherapy drug – teplizumab. She said: “Being part of the ELSA study has helped us as a family to prepare for the future in a way we never expected. Knowing what’s coming – rather than being taken by surprise – has made an enormous difference to our confidence and peace of mind.

“When I was diagnosed, I had no warning and ended up quite poorly in hospital with diabetic ketoacidosis (DKA). When Imogen’s diagnosis arrives, we hope that having this awareness will reduce her chances of experiencing DKA and the added trauma that comes from a sudden illness.

“Imogen took part in the study to further research and help others, but it has helped her too – being forewarned is being forearmed. She was always going to develop type 1 diabetes, but through ELSA we’ve been able to slow down the process and prepare – we know what is coming, but we’re not scared.”

A game-changer: showing what we can achieve in Birmingham

Professor Neil Hanley, Pro-Vice-Chancellor and Head of the College of Medicine and Health at the University of Birmingham, said, “This is a game-changer. This trial shows we can spare countless children the trauma of an emergency diagnosis, ensure they get early support, and potentially give them access to revolutionary new treatments that could delay or even prevent type 1 diabetes.

“Dr Parth Narendran and his team deserve huge credit; and this breakthrough shows what we can achieve in Birmingham. We have world-class clinicians and scientists working side-by-side, backed by great innovation infrastructure and a vibrant, diverse and affordable city – and, as a result, we are changing lives with next generation diagnostics, therapeutics, and clinical care.”

Rewriting the story of type 1 diabetes

Dr Elizabeth Robertson, Director of Research and Clinical at Diabetes UK, said: “For too many families, a child’s type 1 diabetes diagnosis still comes as a frightening emergency. But that doesn’t have to be the case. Thanks to scientific breakthroughs, we now have the tools to identify children in the very earliest stages of type 1 diabetes – giving families precious time to prepare, avoid emergency hospital admissions, and access treatments that can delay the need for insulin for years.

“The ELSA study, co-funded by Diabetes UK, is generating the evidence needed to make type 1 diabetes screening a reality for every family in the UK. We’re incredibly grateful to the 37,000 families who’ve already signed up and urge others to get involved. Together, we can transform type 1 diabetes care for future generations.”

Rachel Connor, Director of Research Partnerships at Breakthrough T1D, said: “This is about rewriting the story of type 1 diabetes for thousands of families. Instead of a devastating emergency, we can offer time, choices, and hope. By finding children in the earliest stages, we’re not just preparing families, we’re opening the door to treatments that can delay the need for insulin by years. That extra time means childhoods with fewer injections, fewer hospital visits and more normality. Thanks to research like ELSA, what once struck as an unexpected crisis can become an actively managed healthcare process, changing the course of T1D for the better.”

The findings from ELSA’s first phase signal a major step towards a future in which type 1 diabetes can be detected early, managed proactively, and potentially delayed through immunotherapy. ELSA demonstrates that childhood screening in the UK is feasible, acceptable to families, and capable of preventing emergency diagnoses. Continued research through ELSA 2 will assess how screening can be scaled across the NHS and evaluate its cost-effectiveness.

Source: University of Birmingham

Categories : Cancer PaediatricsTags :

Childhood Leukaemia Aggressiveness Depends on Timing of Genetic Mutation

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Credit: National Cancer Institute

A team of researchers at the Icahn School of Medicine at Mount Sinai has uncovered why children with the same leukaemia-causing gene mutation can have dramatically different outcomes: it depends on when in development the mutation first occurs.  

The study, led by Elvin Wagenblast, PhD, Assistant Professor of Oncological Sciences, and Pediatrics, at the Icahn School of Medicine at Mount Sinai, was published in Cancer Discovery. It shows that leukemia beginning before birth is often more aggressive, grows faster, and is harder to treat. This adds a missing dimension to precision medicine for childhood leukaemia. 

Dr. Wagenblast and his team at the Wagenblast Lab set out to answer a central question about how a normal blood stem cell can become cancerous. They applied cutting-edge CRISPR/Cas9 genome-editing approaches in human primary blood stem cells to model different developmental stages of acute myeloid leukaemia, one of the most aggressive types of blood cancer. 

Using CRISPR technology, the team induced the NUP98::NSD1 fusion oncoprotein, a cancer-promoting protein created when two genes abnormally fuse, into human blood stem cells from multiple developmental stages, ranging from prenatal to postnatal, adolescence, and adulthood. This approach created the first humanised experimental model that tracks how the same mutation behaves differently depending on when in life it arises. 

The results were striking: stem cells produced during prenatal development transformed easily into leukaemia, creating a highly aggressive and more primitive form of leukaemia. Stem cells produced postnatally became increasingly resistant to transformation and required additional mutations to become cancerous. Prenatal-origin leukaemia stem cells, which are abnormal blood stem cells that arise before birth and can cause certain childhood leukaemias, were more dormant (quiescent) and relied heavily on certain energy sources specific to the cancer state, which were not seen in the leukaemias that originated later in life. Although these prenatal leukaemia stem cells were more dormant, this quiescent state makes them harder to eliminate with standard treatments, helping explain why prenatal-origin leukaemias behave more aggressively, despite identical genetics. 

By analysing single-cell gene expression data from their models, the investigators identified a prenatal gene signature that predicts whether a child’s leukaemia likely began before birth. In patients, this signature strongly correlated with significantly worse clinical outcomes. 

“This work tells us that age matters at the cellular level,” said Dr Wagenblast. “The same mutation behaves very differently depending on when it happens. Understanding this gives us a new way to identify the highest-risk patients and to tailor therapies that go beyond standard genetic classifications.” 

The team tested therapies against the most aggressive leukaemia stem cells and discovered that these cells were especially vulnerable to venetoclax, a Food and Drug Administration-approved drug already used in the clinic. Venetoclax-based combinations, including with standard chemotherapy, significantly reduced aggressiveness in the experimental models. 

“These findings give clinicians mechanistic support to use venetoclax combinations in NUP98-rearranged acute myeloid leukaemia, particularly in younger patients whose disease likely started before birth,” said Dr Wagenblast. 

Understanding when leukaemia begins may help doctors choose more effective therapies earlier, reducing trial-and-error approaches and preventing resistance and relapse later on. 

Conceptually, the study shifts how scientists understand childhood cancer. The developmental timing of the first mutation is not a minor detail. It fundamentally shapes disease biology, treatment resistance, and relapse risk. 

The research opens the door to new diagnostic tools that can identify prenatal-origin leukaemias, venetoclax-based combination therapies that more precisely target vulnerable leukaemia stem cells, and clinical trials that incorporate developmental timing into risk assessment. 

Next, the team plans to develop therapies that more directly target the metabolic program unique to prenatal-origin leukaemias, with the goal of selectively eliminating leukaemia stem cells while sparing healthy blood stem cells. 

Source: Mount Sinai

Categories : Diet and Nutrition PaediatricsTags :

Major Study Highlights Benefits – and Risks – of Plant-based Diets in Children

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Photo by cottonbro studio

Vegetarian and vegan diets can support healthy growth when carefully planned with appropriate supplementation, finds a major new meta-analysis – the most comprehensive study to-date of plant-based diets in children.

A team of researchers, from Italy, USA and Australia, analysed data from over 48 000 children and adolescents worldwide who followed different dietary patterns, examining health outcomes, growth and nutritional adequacy. They found that vegan and vegetarian diets can be nutrient-rich and support healthy growth, but also carry a risk of deficiencies if key nutrients are not obtained through fortified foods or supplements.

The peer-reviewed study, published in Critical Reviews in Food Science and Nutrition, also suggests that plant-based diets may offer additional health benefits for children – including improved cardiovascular risk profiles – compared with omnivorous diets that include meat, fish and other animal-derived foods.

This large meta-analysis is the most comprehensive study to date of plant-based diets in children under 18 years of age, examining data from 59 studies across 18 countries. It compared lacto-ovo-vegetarian (which include dairy products and eggs, but exclude meat, fish and poultry) and vegan diets (which exclude all animal-derived foods) with omnivorous diets across a wide range of nutritional and health outcomes in 7280 lacto-ovo-vegetarians, 1289 vegans and 40 059 omnivores.

The study found that vegetarian children consumed more fibre, iron, folate, vitamin C and magnesium than omnivores, but they had lower intakes of energy, protein, fat, vitamin B12 and zinc. While evidence on vegan diets was more limited, similar patterns emerged.

“Notably, vitamin B12 didn’t reach adequate levels without supplementation or fortified foods, and calcium, iodine and zinc intakes were often at the lower end of recommended ranges, making them important nutrients to consider for children on plant-based diets,” explains the study co-author Dr Jeannette Beasley, an Associate Professor in the Departments of Nutrition and Food Studies and Medicine at New York University.

“Vegan children, in particular, had especially low calcium intake.”

Health benefits

Despite these risks, both vegan and vegetarian children displayed more favourable cardiovascular health profiles than omnivores, with lower total and low-density lipoprotein (LDL) cholesterol – the “unhealthy” form of cholesterol.

Growth and body composition measures indicated that children on plant-based diets tended to be leaner than omnivores: vegetarian children were slightly shorter and lighter, with lower body mass index (BMI), fat mass and bone mineral content. Vegan children also had shorter stature and lower BMI scores.

“Our analysis of current evidence suggests that well-planned and appropriately supplemented vegetarian and vegan diets can meet nutritional requirements and support healthy growth in children,” states lead-author Dr Monica Dinu, who focuses on exploring how nutrition shapes health and well-being at the Department of Experimental and Clinical Medicine, at the University of Florence, in Italy.

Parents: take an informed approach

Plant based diets remain entirely achievable for children and can offer environmental advantages as well as health benefits. The authors stress that families should not be discouraged from choosing vegetarian or vegan diets for ethical, environmental or health reasons. Instead, they recommend that parents approach these diets with informed planning and, where possible, seek support from clinicians such as dietitians and paediatric health professionals. With attention to a few key nutrients, these diets can fully meet children’s needs during periods of rapid growth while reducing nutritional risks.

“We hope these findings offer clearer guidance on both the benefits and potential risks of plant-based diets, helping the growing number of parents choosing these diets for health, ethical or environmental reasons,” Dr Dinu adds.

More research needed, but balance is key

The authors also emphasise the need for clear, evidence-based guidance to support families with planning healthy plant-based diets for children, who may have higher nutritional needs during periods of rapid growth and development.

However, the researchers caution that these results are limited by the cross-sectional design of most included studies, variability in methods and populations, and challenges in accurately assessing children’s dietary intake.

“In conclusion,” says fellow co-author Dr Wolfgang Marx, from the Food & Mood Centre, at Deakin University, Australia, “while well-planned vegetarian and vegan diets are nutritionally adequate and beneficial for adults, there is far less clarity about their suitability for children – leading to inconsistent or even conflicting advice for parents.

“Our findings suggest that a balanced approach is essential, with families paying close attention to certain nutrients – particularly vitamin B12, calcium, iodine, iron and zinc – to ensure their children get everything they need to thrive.”

Source: Taylor & Francis

Categories : Healthcare Politics and Regulations PaediatricsTags : 2 Comments

Warning: Selenium and Zinc Picolinate-containing Products for Children

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Photo by Towfiqu barbhuiya on Unsplash

Pretoria, 8 January 2026 – The South African Health Products Regulatory Authority (SAHPRA) has been made aware of products in the market containing Zinc picolinate (as a source material for zinc) and/or Selenium intended for use in children.

Both of these ingredients have been identified in the Guidance (SAHPRA Guideline 7.04 / SAHPGL-PEM-COMP-04 v5 CM SE Health Supplements) issued by SAHPRA as not permitted in health supplements for children (persons under the age of 18).

The safety concerns related to children are as follows:

  1. Zinc picolinate, at any supplemental dose, can cause side effects which include indigestion, diarrhoea, headache, nausea, and vomiting. As the bio-availability of Zn from Zn-picolinate is variable due to multiple factors, the risk of side effects may be higher and unpredictable, and it is unsuitable as a source of elemental zinc supplementation in children; and
  2. Selenium, when supplemented to children, represents a safety concern considering the potential differences in selenium daily intake between different population groups. While selenium intake is a viable requirement for children in areas of famine or dietary restriction, the potential adverse effects of selenium overdose are of concern when provided in general supplements/medicines intended for children.

The products currently on the market are marketed and sold, among others, as “Immune boosters” for children, with the main active ingredients being Zinc (when derived from Zinc picolinate) and/or Selenium intended for use in children. These products are indicated for supporting the treatment of colds, flu, diarrhoea, and skin-related conditions, rendering the products in question medicines that require registration by SAHPRA.

Any medicine sold that contains Zinc picolinate or Selenium intended for use in children does not qualify as a Category D (complementary) medicine. As such, their sale as a Category D medicine is illegal. Therefore, with effect from the date of publication of this notice, all selenium and zinc picolinate-containing products intended for use in children shall be subject to registration as a medicine falling into Category A, as defined in Section 14(2) of the Medicines and Related Substances Act, 101 of 1965, and need to be submitted to SAHPRA for registration. The sale of Category D (complementary) medicines containing Zinc picolinate or Selenium and intended for use in children must be withdrawn from the market within six (6) months of the date of this publication.

Advice for health professionals and distributors:

SAHPRA requests that Health professionals cease all distribution, selling, and/or dispensing and remove all selenium and zinc picolinate-containing products intended for use in children from stores, storage facilities, and shelves.

Members of the public are urged to return products containing Zinc Picolinate and Selenium when intended for use in children, to their pharmacist, supplying warehouse, or distributor.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product by using the Med Safety App. Your report will contribute to our monitoring of these health products.

Source: SAHPRA

Categories : PaediatricsTags :

Rise in ADHD Diagnoses can Leave Parents Confused About ‘Typical’ Behaviour for Kids

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Children have higher energy levels than adults – but what is ‘typical’ behaviour?

Photo by Annie Spratt on Unsplash

Parents of children who fidget, daydream, and enjoy running and jumping should not automatically be concerned about ADHD.

This is the argument of a team of experts, comprised of a paediatrician, social worker and occupational therapist. They say it is important to attempt to alleviate confusion among parents around what is ‘typical’, and when children need professional help for developmental or behavioural differences.

Based on extensive evidence, their new book Developmental and Behavioral Complexities in Children highlights how the prevalence of ADHD, autism spectrum disorder, and some other developmental and behavioural diagnoses has increased – although they suggest it is not clear if this is because more people are aware of the conditions, screening has improved, changes in the diagnostic criteria have occurred, and/or if there is a genuine increase in the population. The increase in public awareness can sometimes lead to parents and caregivers questioning whether their child’s behaviour is different from others.

Jo-Ann Blaymore Bier, a retired developmental-behavioural paediatrician from Boston Children’s Hospital, occupational therapist Theresa A. Johnson, and Ellen Mullane who is a social worker, also say that opinions can differ among professionals which adds to the uncertainty for people who have children.

“The field of child development is not always a ‘black and white’ science,” they add.

“The way that children behave varies under different conditions and settings. Professionals may have varying thresholds for recommending intervention.

For example, they say: “Being energetic does not necessarily mean that a child has ADHD. Most children enjoy movement, and young children have limited attention spans.

Based on latest research and clinical experience, the experts offer strategies to manage problematic behaviours and examine the evidence behind available treatments.

The book is intended for advanced level students and professionals working in the field of child development, but may also be beneficial for parents and other caregivers who may have concerns. The book also answers questions that caregivers often ask such as is it my child’s personality or something more serious?

The authors, who have helped thousands of children, document a range of ‘typical’ behaviours as well as those likely to be symptoms of specific diagnoses, including autism, ADHD, and oppositional defiant disorder.

In the book, they emphasise that no one demonstrates what others consider acceptable behaviour all the time, and that all children are ‘wired’ differently.

ADHD is the most common childhood neuro-behavioural disorder, with some data sources indicating that about a million more children and adolescents in the US were diagnosed with ADHD in 2022 compared to 2016.

Increased awareness, changes in diagnostic criteria and in social norms are among many factors which the authors of Developmental and Behavioral Complexities in Children suggest may have contributed to the rise in cases.

However, no single specific medical test exists for ADHD. Clinicians make an assessment based on the child’s clinical presentation and on information from people who have observed the child’s behaviour.

For instance, children who are more energetic than their peers but also ‘function in group activities’ may not necessarily have ADHD,  according to the authors.

Autism spectrum disorder (ASD) is also on the rise and is examined in detail in the book. The authors say the ASD diagnosis may have become even more complex – instead of easier – to understand.

The term ‘neurodiversity’ has also become increasingly used. In the book, the authors say: “Accepting and encouraging individuality can be positive goals. But if an individual’s differences are having a negative impact on their functioning, providing supports to improve their quality of life can be beneficial.”

Source: Taylor & Francis

Categories : PaediatricsTags :

Sleep Practices During Infant Illnesses May Increase Risk of Sudden Infant Death

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Photo by Toa Heftiba on Unsplash

When a child falls ill, caregivers often change how and where the infant sleeps – wanting to keep them close through the night. But new research from Johns Hopkins Children’s Center suggests that some of these changes – although well-intentioned – contradict proven safe sleep practices for infants, and may do more harm than good.

In interviews with more than 100 caregivers of infants ages birth to 12 months presenting to the emergency department for infant illness, researchers found that unsafe sleep practices became more common during periods of illness – and often persisted even after the illness resolved. These changes to sleep practices increase an infant’s risk of sudden unexpected infant death (SUID), a broad term that includes sudden infant death syndrome (SIDS). SUID, defined as the unexpected sudden death of a seemingly healthy infant from known and unknown causes, resulted in the deaths of 3700 infants in 2022, according to federal health statistics.

Numerous studies over past decades have tied unsafe sleep practices to both SIDS and SUID. Findings from the new study published in Pediatrics add to evidence that infant illness is a risk factor for SUID.

Caregivers were asked about the infants’ usual sleep practices, and if they changed when the babies were sick. The caregivers reported that adherence to safe habits, such as putting their infants in a crib or playpen, declined overall from 61.8% before illness to 48.1% during illness. In addition, the proportion of caregivers reporting their infants sleeping in a bed or on a couch rose from 56.5% before illness to 62.6% during illness, and further increased to 75% at the one-month follow-up. Similarly, bed-sharing rates increased overall from 57.3% before illness to 68.7% during illness, and further increased to 83.6% at the one-month follow-up.

Many caregivers in the study reported shifts away from recommended safe sleep practices, such as placing infants on their backs to sleep, during infant illness. The most common changes included increased bed-sharing, sleeping on non-recommended sleep surfaces, and prone or side positioning, which are not in line with the American Academy of Pediatrics safe sleep recommendations.

The fact that the alterations persisted beyond the illness period highlights the need for targeted interventions to reinforce safe sleep practices during illness, says Mary Beth Howard, MD, MSc, paediatric emergency medicine physician at Johns Hopkins Children’s Center and lead researcher on the study.

“Parents often make these changes because they want to comfort or closely watch their sick baby, but these well-intentioned adjustments actually raise the risks of sudden, unexpected death. Illness is a particularly vulnerable time, making it even more important to stick to safe sleep guidelines,” says Howard.

The Johns Hopkins investigators note that October is Sudden Infant Death Syndrome (SIDS) Awareness Month, a time to encourage safe infant sleep practices. According to the American Academy of Pediatrics, safe sleep practices include placing infants on their backs to sleep, having infants sleep alone without blankets, pillows or stuffed animals, and having babies sleep in a crib or bassinet.

Source: Johns Hopkins Medicine

Categories : PaediatricsTags :

Use of Social Media Linked to ADHD-like Symptoms in Kids

On By ModernMedia

Increased ADHD-related symptoms in children were linked to social media use, but not video games and television

Photo by Emily Wade on Unsplash

Children who spend a significant amount of time on social media tend to experience a gradual decline in their ability to concentrate. This is according to a comprehensive study from Karolinska Institutet, published in Pediatrics Open Science, where researchers followed more than 8000 children from around age 10 through age 14.

The use of screens and digital media has risen sharply in the past 15 years, coinciding with an increase in ADHD diagnoses in Sweden and elsewhere. Researchers at Karolinska Institutet in Sweden and Oregon Health & Science University in the USA have now investigated a possible link between screen habits and ADHD-related symptoms.

The study followed 8324 children aged 9–10 in the USA for four years, with the children reporting how much time they spent on social media, watching TV/videos and playing video games, and their parents assessing their levels of attention and hyperactivity/impulsiveness. 

Social media stands out

Children who spent a significant amount of time on social media platforms, such as Instagram, Snapchat, TikTok, Facebook, Twitter or Messenger, gradually developed inattention symptoms; there was no such association, however, for watching television or playing video games.

“Our study suggests that it is specifically social media that affects children’s ability to concentrate,” says Torkel Klingberg, professor of cognitive neuroscience at the Department of Neuroscience, Karolinska Institutet. “Social media entails constant distractions in the form of messages and notifications, and the mere thought of whether a message has arrived can act as a mental distraction. This affects the ability to stay focused and could explain the association.”

Significance at population level

The association was not influenced by socioeconomic background or a genetic predisposition towards ADHD. Additionally, children who already had symptoms of inattentiveness did not start to use social media more, which suggests that the association leads from use to symptoms and not vice versa.

The researchers found no increase in hyperactive/impulsive behaviour. The effect on concentration was small at the individual level. At a population level, however, it could have a significant impact.

“Greater consumption of social media might explain part of the increase we’re seeing in ADHD diagnoses, even if ADHD is also associated with hyperactivity, which didn’t increase in our study,” says Professor Klingberg.

Well-informed decisions

The researchers stress that the results do not imply that all children who use social media develop concentration difficulties, but there is reason to discuss age limits and platform design. In the study, the average time spent on social media rose from approximately 30 minutes a day for 9-year-olds to 2.5 hours for 13-year-olds, despite the fact that many platforms set their minimum age requirement at 13. 

“We hope that our findings will help parents and policymakers make well-informed decisions on healthy digital consumption that support children’s cognitive development,” says the study’s first author Samson Nivins, postdoctoral researcher at the Department of Women’s and Children’s Health, Karolinska Institutet.

The researchers now plan to follow the children after the age of 14 to see if this association holds. 

Source: Karolinska Institutet

Categories : Dermatology PaediatricsTags :

Do Babies Really Need Sunscreen? The Risks of Overuse and Underuse

On By ModernMedia
Photo by Marissa Daeger on Unsplash

When it comes to protecting babies from the sun, many parents wonder if sunscreen is safe and necessary. The truth is, experts advise against using sunscreen on infants under six months old as their skin is thinner and more sensitive, leading to greater absorption of chemicals and a higher risk of irritation and rashes.

Babies under six months have a higher surface-area-to-body-weight ratio, which increases their exposure to sunscreen chemicals. Some chemical ingredients, like oxybenzone, may cause allergic reactions or disrupt hormones. Sunscreen can also impede a baby’s ability to sweat and regulate their body temperature. 

Instead, the best protection for young babies is to keep them out of direct sunlight, dress them in lightweight, long-sleeved clothing, and use hats and shade as natural barriers. 

For babies over six months, a gentle, broad-spectrum baby sunscreen with at least SPF 30 can be safely applied. However, using sunscreen should complement, not replace, other sun safety measures, which are vital – especially in our sunny South African climate! 

Karen Van Rensburg, spokesperson for Sanosan, explains, “Parents often struggle with knowing how much sunscreen to use on their babies. It’s important to understand that while sunscreen is a helpful tool, relying solely on it, especially for very young infants, can be risky. Using physical barriers like shade and protective clothing alongside sunscreen provides the safest approach to sun care for babies.”

To keep babies safe, parents should:

  • Avoid sun exposure during peak hours (10 a.m. to 4 p.m.)
  • Use shade and protective clothing as the first defence.
  • For babies over six months, reapply a suitable sunscreen on a regular basis to maintain protection, especially after going in the water, after drying off or after sweating. 
  • Your baby should not stay in the sun too long even with sunscreen because every sunburn damages the skin and is a serious risk to their health. 

This balanced approach highlights that cautious sunscreen use combined with physical protection methods is key to keeping baby skin healthy and safe from sun damage.

Sanosan Baby Sun Cream SPF 50+ is a top-tier sunscreen designed specifically for delicate baby skin including broad range of UVA+UVB protection SPF 50+. With its pleasant texture, this cream absorbs quickly for easy application and delivers 24 hours of nourishing care, making it suitable for babies, children, and adults alike. With its gentle formula, this sun cream helps maintain skin hydration while protecting against sun damage, allowing for worry-free outdoor playtime. Plus, its microplastic-free, and safe for our oceans!

Categories : Mental Health PaediatricsTags :

Social Media Use Drives Distrust Among Gen Z Teenage Girls

On By ModernMedia
Photo by Freestocks on Unsplash

Social media use in adolescence is linked to delayed bedtimes, negative self-image and, especially among teenage girls, greater distrust, shows a new study from University College London. In turn, these changes are associated with more symptoms of depression and anxiety, risk of self-harm, and suicidal behaviours several years later. 

Published in Social Psychiatry and Psychiatric Epidemiology, the study examined how use of social media on the cusp of adolescence (11-years-old) was indirectly associated with a range of psychiatric symptoms, including psychological distress, self-harm and suicidal behaviours, in late adolescence (17-years-old). 

The study found three mechanisms linking social media use in early adolescence to small overall increases in subsequent mental health problems. Both boys and girls who were using social media from early on (at age 11) tended to sleep a little later on average, and had more negative thoughts about their physical appearance at age 14, compared to those who had not used social media. Crucially, teenage girls who had been using social media at age 11 reported greater distrust of other people at age 14.  

The three key mechanisms, which involved later bedtimes, more negative perceptions of body image, and distrust, mediated the association between early social media use and subsequent mental health problems. These small but significant relationships held true even after adjusting for socioeconomic and demographic factors, any maternal mental health problems, and children’s prior mental health difficulties (at age 7).  

The findings were based on data from the UK’s nationally representative Millennium Cohort Study, which was designed to track the lives of around 19 000 children born in 2000 to 2001 (and who belong to ‘Gen Z’, that is, children born between 1997 and 2012).  

During 2011-2012, at around age 11, the participants were asked: “How often do you visit a social networking website on the internet, such as Facebook or Bebo?”. Around three years later, they were followed up and asked about their usual bedtime, their trust in others, and their self-perception. A range of mental health challenges were subsequently tracked another three years later, at age 17. 

Lead author, Dr Dimitris Tsomokos (UCL Institute of Education) said: “These findings suggest that interpersonal distrust was a significant driver of psychiatric symptoms among Gen Z girls who used social media from early adolescence. 

“This distrust of others may be a particularly female response to the pressures of social media, which can sadly be fertile ground for social comparison, cyberbullying and perceived exclusion.” 

“We know that teenage girls display more empathetic concern and tend to place higher value on reciprocal relationships, and perhaps this is what drives greater distrust among them.” 

As policymakers and parents grapple with how to navigate technology use in childhood, the study’s authors recommend greater intervention in early adolescence, focused on fostering a sense of trust and social safety. They believe this can help mitigate the negative impacts of social media usage on young people’s long term mental health. 

Source: University College London