In emergency medicine, triage differentiates patients who require immediate attention from those who can safely wait for care. When it comes to children’s mental or behavioural health, however, triage scores were found to be inaccurate in two-thirds of the cases when compared to the level of care the child actually received during their emergency visit, according to a new study published in JAMA Network Open. Under-triage, or assignment of a lower severity score than the level of care that was needed, was more likely for children who were Black, Hispanic, and those who preferred Spanish compared to English.
“Our study was the first to examine rates of mis-triage in paediatric emergency departments when children present for mental or behavioural health concerns,” said lead author Jennifer Hoffmann, MD, MS, emergency medicine physician and researcher at Ann & Robert H. Lurie Children’s Hospital of Chicago and Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “When triage determination is wrong, there might be a risk to patient and staff safety, or resources might be diverted from kids in greater need. Especially with the ongoing youth mental health crisis, and as we continue to see more and more children with these issues in the emergency department, our ability to accurately distinguish levels of urgency upon arrival becomes even more critical. We need to refine triage tools to be more accurate and equitable so that they will work for all children who walk through our doors seeking care.”
Dr Hoffmann and colleagues analysed 74 564 visits for mental or behavioural health complaints among children 5-17 years of age presenting to one of 15 U.S. emergency departments participating in the Pediatric Emergency Care Applied Research Network (PECARN) Registry. The study focused on the Emergency Severity Index (ESI), the triage system used in over 90% of U.S. emergency departments.
The most frequently presenting primary mental health diagnosis groups were depressive disorders (25% of visits) and suicide or self-injury (23% of visits). Aggressive behavior occurred in 24% of the visits.
Over-triage, which involves assigning a higher severity triage score than the level of care the child received throughout their emergency visit, was found in more than half (57%) of visits, while under-triage occurred in approximately 1 in 12 visits (8%). Over-triage was more likely during visits by younger patients and Black patients compared to White patients. Under-triage was more likely among visits by Black and Hispanic patients compared to White patients, as well as in visits with a language preference of Spanish relative to English.
“The main message for parents is to advocate for your child. If you are worried that your child is at risk of harming themselves or others while they are waiting, tell the nurse immediately,” Dr. Hoffmann advised.
“Underlying drivers for inequities in triage may include implicit bias, which refers to unconscious stereotypes or attitudes,” said Dr Hoffmann. “Clinicians need education on recognizing their own biases, in order to avoid undue influence on the care they provide. Using automated tools or artificial intelligence (AI) to augment the nurse’s assignment of triage scores might help achieve a more objective assessment, although these strategies require further testing. We also need to make interpretation services in the emergency department more readily accessible to families who prefer a language other than English. Ultimately, accurate and equitable triage systems are needed to match children with the right care at the right time, particularly during times of resource strain.”
A new Cochrane review finds that chlorhexidine likely cuts umbilical cord infection rates by about 29% in low- and middle- income countries, and may reduce newborn deaths.
Umbilical cord care is a key part of newborn hygiene that helps prevent infection and promotes healthy healing. According to the World Health Organization (WHO), approximately 2.3 million newborn babies died in 2023, with the highest burden in low- and middle-income countries (LMICs).
Cord care practice varies widely around the world, shaped by local culture, healthcare infrastructure and available resources.
In settings with adequate obstetric care and low neonatal mortality, current WHO guidelines recommend dry cord care, involving keeping the stump clean and dry without antiseptics. In settings with higher neonatal mortality, the guidelines recommend daily application of 4% chlorhexidine for a week.
Antiseptic cord care offers protection
The researchers systematically reviewed 18 randomised controlled trials involving 143 150 newborns to evaluate whether applying antiseptics to the umbilical cord stump reduces infection, death, or delays cord separation compared to no treatment. The review covered antiseptics including 4.0% chlorhexidine (CHX), 70% alcohol, silver sulfadiazine, and povidone iodine.
The findings show that applying chlorhexidine to newborns’ umbilical cords likely reduces the number of infections from around 87 to 62 per 1000 newborns and the numbers of deaths may fall from around 18 to 15 per 1000 newborns in LMICs. Chlorhexidine likely also delays the time it takes for the cord stump to fall off by one to two days.
Only one study from a high-income country evaluated chlorhexidine. Evidence for preventing the bacterial infection omphalitis and its effect on cord separation was very uncertain, meaning conclusions cannot be drawn for these settings at this time.
“In many parts of the world, newborns are still born into environments where hygiene conditions are poor. Simple and accessible cord-care interventions can significantly reduce infections in these settings, which is critical given the large share of neonatal deaths linked to infection.”
– Dr Aamer Imdad, University of Iowa
Evidence for alcohol use in LMICs was very uncertain for both infection prevention and cord separation time. In high-income countries, moderate-certainty evidence suggests alcohol delays cord separation by approximately 1.6 days, but no studies reported on mortality or omphalitis in these settings.
Umbilical cord care should be contextualised to local settings
Dry cord care remains the recommended approach in countries with adequate obstetric care and low neonatal mortality. The authors explain that in many places, clean and dry cord care may be sufficient, while in others antiseptic approaches can reduce infection risk. The key is choosing interventions that match the realities families and health systems face.
“Our findings broadly support current World Health Organization guidance, but they also underline an important point: these interventions are not necessarily universal solutions. The benefits depend strongly on the context in which babies are born. What works best depends on local circumstances.”
– Professor Zulfiqar Ahmed Bhutta, Centre for Global Child Health in Canada and Aga Khan University in Pakistan
Many studies did not share individual patient data, which the authors say would have helped answer some remaining questions more clearly. Greater and timely data sharing could greatly strengthen transparency and in-depth scientific analysis for policy.
Children living with obesity but showing no signs of metabolic complications still have a significantly increased risk of developing type 2 diabetes, high blood pressure, and abnormal blood lipid levels later in life. A new study from the Karolinska Institutet, published in JAMA Pediatrics, also shows that these children benefit greatly from obesity treatment.
“There has been a debate about whether children with normal blood and liver values and normal blood pressure might not need treatment for their obesity. Our study shows that this assumption is incorrect,” says Claude Marcus, professor at the Department of Clinical Science, Intervention and Technology, Karolinska Institutet.
The study included just over 7200 children aged 7–17 who had begun obesity treatment in Sweden and were followed up until age 30. The researchers compared children with so-called metabolically healthy obesity (MHO), children with obesity and impaired cardio-metabolic risk markers (MUO), and peers from the general population.
A clearly increased risk
By age 30, 9% of the children with MHO had developed type 2 diabetes, compared with 17% of those with MUO and 0.5% in the control group. Similar patterns were observed for high blood pressure (11% in the MHO group, 18% in the MUO group, and 4% in the control group) and abnormal blood lipids (5 and 13%, respectively, compared to 1% in the general population).
“Even children with obesity who show no signs of cardiometabolic impact have a clearly increased risk of future diseases. This means that normal blood pressure and the absence of abnormal blood test results are not sufficient protection against future morbidity,” says Emilia Hagman, associate professor at the Department of Clinical Science, Intervention and Technology, Karolinska Institutet, and the paper’s corresponding author.
All children need treatment
All children in the study received support for healthier lifestyle habits, and the researchers also investigated whether the treatment response affected the risk of future illness in the different groups. A good treatment response during childhood was linked to a reduced risk of all the diseases studied. The effect was equally significant in both the MHO and MUO groups.
“Our results suggest that all children with obesity need treatment, even if they appear completely healthy upon examination,” says Claude Marcus.
The study is based on data from the national quality registry BORIS and several Swedish health data registries. The research was funded by, among others, the Center for Innovative Medicine, the Ollie and Elof Ericsson Foundation, and the Freemason Foundation for Children’s Welfare. Several of the researchers report compensation from companies unrelated to this work. See the scientific article for a complete list of conflicts of interest.
A major UK-led clinical trial has found that a treatment commonly used to help premature babies breathe offers no benefit for infants on life support with severe bronchiolitis – a seasonal viral illness that hospitalises thousands of babies each year.
Funded by a partnership between the UK’s UKRIMedical Research Council (MRC) and National Institute for Health and Care Research (NIHR), and by Chiesi Farmaceutici SpA, Italy, the Bronchiolitis Endotracheal Surfactant Study (BESS) trial is the largest-ever randomised study of surfactant for bronchiolitis.
Bronchiolitis occurs when a virus – most commonly respiratory syncytial virus (RSV) – infects a baby’s lungs. There is currently no specific treatment for RSV infection, and the illness can be especially severe in premature and newborn infants. Babies with bronchiolitis have reduced levels of surfactant in their lungs, a condition similar to that seen in babies born prematurely. Because surfactant is routinely used to help premature infants breathe more easily, the study team set out to determine whether this therapy could also benefit babies hospitalised with bronchiolitis.
The study ran across 15 children’s hospitals in England, Scotland, and Northern Ireland and involved 232 critically ill babies. However, surfactant did not reduce the time they needed to be on a ventilator (life-support breathing machine).
Professor Calum Semple OBE, the study’s lead from the University of Liverpool and Alder Hey Children’s NHS Foundation Trust, said: “The treatment was safe, but it didn’t make any difference to how long babies stayed on ventilators. We had hoped that surfactant might speed up recovery for these very sick babies, but the evidence doesn’t support this.”
Bronchiolitis is the leading reason why babies are admitted to hospital in the UK during winter. It typically affects babies under one year old and can be especially severe in those born prematurely. While most of the twenty-five thousand babies admitted will recover with oxygen and fluids, around a thousand of the most unwell require intensive care and a ventilator to support their breathing. Currently, there is no other treatment for bronchiolitis, but a vaccine is now being offered to the mother-to-be in the last months of pregnancy.
The BESS trial was designed to give families and clinicians clear answers. It ran over six winter seasons from 2019 to 2024.
Professor Semple added: “While we continue to research better ways to care for these sick babies, I urge Mums-to-be to accept the offer of the RSV vaccine during pregnancy, which will protect their newborn babies from severe bronchiolitis.”
The researchers emphasise that surfactant therapy remains essential for premature newborn babies and advocate for further studies to explore targeted treatments for bronchiolitis.
Trial provides new evidence to guide early treatment decisions for families and clinicians
An infant participating in the Baby CHAMP study raises both hands while seated in a stroller. The NIH-funded trial led by the Fralin Biomedical Research Institute at VTC examines early therapies designed to improve arm and hand function in young children with cerebral palsy affecting one side of the body. Credit: Jennifer Murray
Infants and toddlers with unilateral cerebral palsy, which affects the brain’s control of muscles on one side of the body, show lasting improvements in hand and arm function when they receive early, high-dose therapy, according to a new multisite clinical trial led by Virginia Tech researchers at the Fralin Biomedical Research Institute at VTC.
The Baby CHAMP (Children with Hemiparesis Arm-and-Hand Movement Project) study directly compared three therapist-delivered interventions: two forms of constraint-induced movement therapy, which limit the stronger arm to encourage use of the weaker one when combined with therapy, and bimanual therapy, which promotes coordinated use of both hands.
The researchers found that children ages 6 to 24 months showed similar gains whether therapy involved full-time casting, a splint worn during sessions, or bimanual training without constraining the stronger arm.
Published in Pediatrics Open Science, the study addresses a long-standing gap in clinical evidence.
“The brain in the first two years of life is remarkably plastic,” said Stephanie DeLuca, associate professor at the Fralin Biomedical Research Institute at VTC and co-principal investigator of the trial. “By delivering high-dose, play-based therapy early, we’re capitalizing on a window of opportunity when the nervous system is especially responsive to experience.”
While both constraint-induced movement therapy and bimanual therapy are widely recommended for children older than 2 years with unilateral cerebral palsy, limited data have been available to guide treatment decisions for infants and toddlers.
“This gives families and clinicians evidence-based options,” said Sharon Landesman Ramey, a Virginia Tech Distinguished Scholar, professor at the Fralin Biomedical Research Institute at VTC, and co-principal investigator of the Baby CHAMP trial. “The encouraging message is that early, intensive therapy works — and multiple approaches can help children build critical motor skills. Caregivers and families now have actionable evidence that can shape care during one of the most important periods of brain development.”
Unilateral cerebral palsy affects movement on one side of the body and can result in lifelong impairment of upper extremity function. Early intervention is considered critical because the brain is especially adaptable during the first two years of life.
DeLuca is director of the Fralin Biomedical Research Institute at VTC Neuromotor Research Clinic, which investigates novel treatments for children with a range of biomedical conditions and provides worldwide training for therapists to become certified in new evidence-based therapies.
All children received three hours of therapy per day, five days a week, for four consecutive weeks, totaling 60 hours of structured intervention. Parents also supported additional guided home practice.
Fifty-eight children were enrolled in the randomized controlled trial, funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Fifty-three completed treatment and end-of-therapy assessments, and 41 returned for evaluation six months later.
Across all three groups, children demonstrated significant improvements in the ability to use both hands, individually and together. Improvements were measured using standardized developmental assessments administered by evaluators who were unaware of each child’s treatment assignment.
Children also showed gains in fine motor skills in their less-affected arm. Improvements were most pronounced at the six-month follow-up, suggesting that benefits continued to build after formal therapy ended.
Researchers had hypothesized that bimanual therapy might lead to greater improvements in two-handed skills and that full-time casting might yield stronger gains in the affected arm. The data did not support those predictions. Instead, outcomes were broadly comparable across approaches.
The study also addressed concerns that constraining the stronger arm could impair its development. No evidence of harm was observed. In fact, children in the full-time cast group showed slightly greater gains in fine motor skills in their non-affected arm at six months compared with the bimanual group.
“This is important to the field because many people have worried that the use of a constraint might slow the developmental process of the less-affected arm,” DeLuca said. “Our findings confirm that this did not occur and this therapy may even help promote improvements in skills on the less-affected arm and hand.”
Some parents reported their child showed short-term frustration wearing a cast or splint, and minor skin irritation occurred in a small number of children using casts, but no were caused by the therapy itself.
The trial was conducted in collaboration with researchers at Virginia Tech, The Ohio State University, and Nationwide Children’s Hospital. Therapists were centrally trained to deliver structured, play-based interventions grounded in motor learning principles, including repetition, reinforcement, and progressively challenging activities.
Longer-term studies will be needed to better understand how early therapy influences development across many dimensions of a child’s life.
Biologics may be more effective with earlier treatment initiation, especially among children with early polysensitisation or multiple early-childhood risk factors, according to the results of a new study published in Annals of the American Thoracic Society. Screening for these risk factors may help inform targeted early initiation of biologics for asthma.
Robust real-world data on the effectiveness of biologic therapies in children with severe asthma remain limited, particularly across different ages and early-life risk profiles. This evidence gap constrains precision in treatment decisions and clinical guidance.
Children with moderate to severe asthma requiring biologic therapy are most affected, especially those initiating biologic treatment at younger ages and those with early indicators of allergic disease or high-risk asthma histories.
Initiating biologic therapy earlier in childhood – particularly in children with significant early-life risk factors and allergic sensitisation – is associated with greater reductions in severe asthma exacerbations in real-world practice.
Findings highlight the importance of treatment timing and patient history when optimizing outcomes with asthma biologics.
Risks of delayed treatment initiation
Delayed initiation of biologic therapy until adolescence or failure to account for early-childhood risk profiles may reduce potential treatment benefit. These findings highlight the risk of suboptimal outcomes when treatment timing or patient selection does not align with underlying disease risk.
Clinicians should prioritise earlier identification and risk-stratified initiation of biologics in children with severe asthma, particularly those with high early-life risk burden, to maximise treatment benefits.
Study findings support development of care pathways that incorporate earlier, risk-stratified biologic initiation. Decision-making algorithms may benefit from integrating age at treatment initiation and early-life risk indicators, such as polysensitisation and high early disease burden, to better identify children most likely to benefit and reduce severe exacerbations.
Future research may also explore the role of clinical artificial intelligence in supporting these approaches. Clinical AI tools could help identify high-risk paediatric patients earlier and guide treatment timing and patient selection by detecting patterns in real-world clinical data, potentially improving precision in biologic therapy use.
Researchers have found that sucrose can relieve newborn babies’ pain during common hospital procedures
Photo by Christian Bowen on Unsplash
A new Cochrane review has found that sucrose can help with pain relief in newborn babies during common hospital procedures, such as venepuncture. This involves drawing blood with a needle, typically for testing.
Newborns, especially preterm infants in neonatal intensive care units (NICUs), undergo numerous painful procedures. Because of their immature pain regulation, they can experience these procedures intensely. Preventing and treating procedural pain in hospitalized newborns is important, as repeated untreated pain has been associated with poorer physical growth and potential effects on brain development.
Accessible, low-cost solutions such as sucrose – a sweet sugar solution placed in a baby’s mouth shortly before needle procedures – have been used for decades. However, evidence specific to some procedures, such as venepuncture, has been limited.
Despite sucrose being recommended in multiple guidelines for procedural pain relief in infants, its use in clinical settings remains inconsistent.
Low-cost, safe intervention
The new review examined 29 clinical trials involving more than 2700 preterm and full-term babies undergoing venepuncture in hospital. It found that sucrose probably reduces pain during and immediately after the needle procedure when compared to no treatment, water or standard care. The findings also suggest that sucrose works especially well when combined with non-nutritive sucking, such as a pacifier or dummy.
“Newborn babies undergo frequent needle procedures in hospital without any pain relief or comforting measures, even though older children and adults rarely have these procedures done without pain care.
The evidence shows that a small amount of sucrose given just before the procedure is a simple, fast and effective way to reduce that pain. Our review helps clinicians use this evidence more confidently and consistently in practice.”
—Mariana Bueno, University of Toronto
None of the studies included in the review reported immediate side effects from sucrose when used in the small amounts required for pain relief. However, the studies focused on short-term effects, and more research is needed to understand any potential long-term effects of repeated use in babies who spend extended time in neonatal care.
“Parents may be surprised to learn that something as simple as a few drops of sugar solution can make a real difference to their baby’s comfort during blood tests.
This is a low-cost, safe intervention that works within minutes, and it can be especially helpful when other comforting methods like skin-to-skin contact or breastfeeding aren’t possible.”
—Ligyana Candido, University of Ottawa
Treated like other medications
Although sucrose is already widely used in neonatal units, the researchers found considerable variation in how it is given, including differences in dose and timing.
Bueno added:
“What stood out to me when doing this review was the wide variation in how sucrose was given to newborns.”
The authors suggest the findings can help inform clearer clinical protocols and more consistent practice.
They also highlight that sucrose should be used purposefully for painful procedures and documented appropriately, rather than being given routinely to settle a crying baby.
“To ensure safety and clinical consistency, sucrose must be administered under formal medication protocols that define specific timing and dosage for painful procedures.”
— Jiale Hu, Virginia Commonwealth University
The review authors say future research should focus on comparing effective comfort measures such as skin-to-skin contact, breastfeeding and sucrose with each other, rather than continuing to compare them to no treatment, and on understanding any potential long-term effects of repeated use in babies who spend extended time in neonatal care.
Newborns listening to Bach music predicted rhythm, but not melody, according to their brain waves
Human newborns can predict rhythmic structure from music, while they are not as good at expecting melodic changes. Image credit: Diego Perez-Lopez, PLOS, CC-BY 4.0
Babies are born with the ability to predict rhythm, according to a study published February 5th in the open-access journal PLOS Biology by Roberta Bianco from the Italian Institute of Technology, and colleagues.
It’s anticipating a beat drop, key change or chorus in a song you’ve never heard. Across all cultures, humans can inherently anticipate rhythm and melody. But are babies born with these behaviours, or are they learned? Research shows that by approximately 35 weeks of gestation, foetuses begin to respond to music with changes in heart rate and body movements. However, newborns’ ability to anticipate rhythm and melody is not fully understood.
To understand babies’ musical aptitudes, researchers played J.S. Bach’s piano compositions for an audience of 49 sleeping newborns. Musical stylings included 10 original melodies and four shuffled songs with scrambled melodies and pitches. While the babies listened, the researchers used electroencephalography – electrodes placed on the babies’ heads – to measure their brainwaves. When the babies’ brain waves showed signs of surprise, it meant they expected the song to go one way, but it went another.
The newborns tended to show neural signs of surprise when the rhythm unexpectedly changed; in other words, the miniature maestros had generated musical expectations based on rhythm. Previously, this result had been observed in non-human primates. The researchers found no evidence that the newborns tracked melody or were surprised by unexpected melodic changes, a skill that comes at an unknown exact point later in development.
According to the authors, understanding how humans become aware of rhythm can help biologists understand how our auditory systems develop. Future studies can investigate how exposure to music during gestation affects acquisition of rhythm and melody.
The authors add, “Are newborns ready for Bach? Newborns come into the world already tuned in to rhythm. Our latest research shows that even our tiniest 2-day old listeners can anticipate rhythmic patterns, revealing that some key elements of musical perception are wired from birth. But there’s a twist: melodic expectations – our ability to predict the flow of a tune – don’t seem to be present yet. This suggests that melody isn’t innate but gradually learned through exposure. In other words, rhythm may be part of our biological toolkit, while melody is something we grow into.”
Study raises questions around why female individuals are diagnosed later than males
Photo by Ben Wicks on Unsplash
Autism has long been viewed as a condition that predominantly affects male individuals, but a study from Sweden published by The BMJ shows that autism may actually occur at comparable rates among male and female individuals.
The results show a clear female catch-up effect during adolescence, which the researchers say highlights the need to investigate why female individuals receive diagnoses later than male individuals.
The prevalence of autism spectrum disorder (ASD) has increased over the past three decades, with a high male-to-female diagnosis ratio of around 4:1.
The increase in prevalence is thought to be linked to factors including wider diagnostic criteria and societal changes (eg, parental age), whilst the high male to female ratio has been attributed to better social and communication skills among girls, making autism more difficult to spot. However so far no large study has examined these trends over the life course.
To address this, researchers used national registers to analyse diagnosis rates of autism for 2.7 million individuals born in Sweden between 1985 and 2022 who were tracked from birth to a maximum of 37 years of age.
During this follow-up period of more than 35 years, autism was diagnosed in 78,522 (2.8%) of individuals at an average age of 14.3 years.
Diagnosis rates increased with each five year age interval throughout childhood, peaking at 645.5 per 100,000 person years for male individuals at age 10-14 years and 602.6 for female individuals at age 15-19 years.
However, while male individuals were more likely to have a diagnosis of autism in childhood, female individuals caught up during adolescence, giving a male to female ratio approaching 1:1 by age 20 years.
This is an observational study and the authors acknowledge that they did not consider other conditions associated with autism, such as ADHD and intellectual disability. Nor were they able to control for shared genetic and environmental conditions like parental mental health.
However, they say the study size and duration enabled them to link data for a whole population and disentangle the effects of three different time scales: age, calendar period and birth cohort.
As such, they write: “These findings indicate that the male to female ratio for autism has decreased over time and with increasing age at diagnosis. This male to female ratio may therefore be substantially lower than previously thought, to the extent that, in Sweden, it may no longer be distinguishable by adulthood.”
“These observations highlight the need to investigate why female individuals receive diagnoses later than male individuals,” they conclude.
These findings align with recent research and seem to support the argument that current practices may be failing to recognise autism in many women until later in life, if at all, says Anne Cary, patient and patient advocate, in a linked editorial.
She notes that studies like this are essential to changing the assumption that autism is more prevalent in male individuals than in female individuals, but points out that as autistic female individuals await proper diagnosis, “they are likely to be (mis)diagnosed with psychiatric conditions, especially mood and personality disorders, and they are forced to self-advocate to be seen and treated appropriately: as autistic patients, just as autistic as their male counterparts.”
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.
