Tag: preterm birth

Categories : PaediatricsTags :

New WHO Guidelines for Preterm Babies Emphasise ‘Kangaroo Care’

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Preterm baby
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WHO today launched new guidelines to improve survival and health outcomes for babies born preterm (< 37 weeks) or small (< 2.5kg). In a significant departure from common clinical practice, the guidelines advise that caregiver skin to skin contact with a caregiver – aka kangaroo mother care – should start immediately after birth, without incubator stabilisation. This reflects the immense health benefits of ensuring caregivers and their preterm babies can stay close, without being separated, after birth.

The guidelines also provide recommendations to ensure emotional, financial and workplace support for families of very small and preterm babies, who can face extraordinary stress and hardship because of intensive caregiving demands and anxieties around their babies’ health.

“Preterm babies can survive, thrive, and change the world – but each baby must be given that chance,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “These guidelines show that improving outcomes for these tiny babies is not always about providing the most high-tech solutions, but rather ensuring access to essential healthcare that is centred around the needs of families.”

Depending on where they are born, there remain significant disparities in a preterm baby’s chances of surviving. While most born at or after 28 weeks in high-income countries go on to survive, in poorer countries survival rates can be as low as 10%.

Most preterm babies can be saved through feasible, cost-effective measures including quality care before, during and after childbirth, prevention and management of common infections, and kangaroo mother care – combining skin to skin contact in a special sling or wrap for as many hours as possible with a primary caregiver, usually the mother, and exclusive breastfeeding.

Previous recommendations for preterm babies were for an initial period of separation from their primary caregiver, with 3–7 days of initial stabilisation in an incubator or warmer. However, research has now shown that starting kangaroo mother care immediately after birth reduces mortality, infections and hypothermia, and improves feeding. 

Breastfeeding is also strongly recommended to improve health outcomes for preterm and low birthweight babies, with evidence showing it reduces infection risks compared to infant formula. Where mother’s milk is not available, donor human milk is the best alternative, though fortified ‘preterm formula’ may be used if there are no donor milk banks.

Integrating feedback from families gathered through over 200 studies, the guidelines also advocate for increased emotional and financial support for caregivers. Parental leave is needed to help families care for the infant, the guidelines state, while government and regulatory policies and entitlements should ensure families of preterm and low birthweight babies receive sufficient financial and workplace support.

Earlier this year, WHO released related recommendations on antenatal treatments for women with a high likelihood of a preterm birth. These include antenatal corticosteroids, which can prevent breathing difficulties and reduce health risks for preterm babies, as well as tocolytic treatments to delay labour and allow time for a course of corticosteroids to be completed. Together, these are the first updates to WHO’s preterm and low birth weight guidelines since 2015.

The guidelines were released ahead of World Prematurity Day, which is marked every year on 17th November. 

Source: World Health Organization

Categories : Gastrointestinal Obstetrics & GynaecologyTags :

Even in Remission, IBD is a Risk Factor for Preterm Birth

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Inflammatory bowel disease is a risk factor for giving birth preterm even when in apparent disease remission, according to a study published in the journal eClinicalMedicine. If corroborated, the results may eventually affect recommendations for women with ulcerative colitis wishing to conceive.

Inflammatory bowel disease (IBD) is chronic inflammatory disease with a prevalence of approximately 0.5%. IBD, which includes ulcerative colitis and Crohn’s disease, and – unlike irritable bowel syndrome (IBS) – causes visible damage to the mucosa lining the intestines. IBD is characteristic for its recurrent tendency for symptoms to relapse, followed by periods of remission.

Onset of IBD commonly occurs at age 15–30, so questions about its impact on pregnancy and the foetus are common. IBD has previously been linked to negative birth outcomes, such as preterm birth (< 37 weeks of pregnancy), mainly in women showing signs of active disease.

Also, women without obvious IBD activity often have microscopic inflammation in the intestinal mucosa. Until now, however, it has been unknown whether even microscopic inflammation may be associated with risks in pregnancy.

Higher risk of preterm birth

The present study, shows that microscopic inflammation in IBD, especially ulcerative colitis, is linked to an elevated risk of giving birth prematurely.

Among babies born to women with microscopic inflammation due to IBD, 9.6% were preterm, while 6.5% of children were born preterm to women without microscopic inflammation of IBD. This corresponds to a relative risk increase of 46 percent. Microscopic inflammation was not clearly associated with other adverse pregnancy outcomes, such as growth restriction.

The results are based on register data on women in Sweden, diagnosed with IBD in 1990–2016, in whom information was available on the microscopic appearance of the intestine shortly before pregnancy. The study included 1223 children of women with microscopic IBD inflammation of the intestine and 630 children of women with IBD but with microscopically healed intestinal mucosa.

Through register linkages, data were also retrieved from several national health registers, such as the Swedish Medical Birth Register and the Swedish Quality Register for Inflammatory Bowel Desiease (SWIBREG).

Prospect of new treatment targets

“Our results suggest that IBD treatment aimed at not merely alleviate symptoms of IBD, but also microscopically heal the intestine, can reduce the risk of giving birth preterm,” sayd first author and corresponding author is Karl Mårild, associate professor of paediatrics at Sahlgrenska Academy, University of Gothenburg. “If our results hold up in future studies, they may therefore be the basis for recommendations to confirm microscopic healing before pregnancy, to reduce such risks.”

“Even a modestly increased relative risk of preterm birth is important, given that preterm birth can greatly affect the child’s health in both the short and the long term. Preterm birth is still one of the most common causes of death for children under the age of five in Sweden,” Karl Mårild concludes.

Source: University of Gothenburg

Categories : Obstetrics & GynaecologyTags :

Targeting Piezo1 Could Treat Preterm Labour

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Pregnant with ultrasound image
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A serious neonatal health threat, preterm labour has long mystified researchers – and how does the uterus normally stay dormant, letting it stretch and expand during the 40 weeks it takes a foetus to grow? New research published in The Journal of Physiology suggests that a protein called Piezo1 keeps the uterus relaxed throughout gestation.

Preterm birth is a major cause of neonatal mortality and morbidity. The identification of Piezo1 in the uterus, and its role to maintain relaxation of uterus through stretch-activation during pregnancy, paves the way for drugs and therapies to be developed that could one day treat or delay preterm labour.

The muscular outer layer of the uterus is peculiar because it is the only muscle that it is not regulated by nerves and it must remain dormant for the 40 weeks despite significant expansion and stretch as the foetus develops into a baby. The researchers from University of Nevada USA studied tissue samples of the smooth muscle of the uterus to explore the mechanistic pathways to better understand the dynamics controlling the uterus, how pregnancy is maintained and what maintains quiescence until labour.

Stretching the uterus tissue, to mimic what happens during pregnancy, activates Piezo1 channels. This drives the flow of calcium molecules generating a signalling cascade that activates the enzyme nitric oxide synthase to produce the molecule nitric oxide. This Piezo1 cascade promotes and maintains the dormant state of the uterus.

Piezo1 controls the uterus by working in a dose-dependent manner, where channel activity is stimulated by the chemical Yoda1 and inhibited by a chemical called Dooku1 (Star Wars fans will no doubt recognise the inspiration behind these two names). When Piezo1 is upregulated, the uterus remains in a relaxed state. However, in preterm tissue, the expression of Piezo1 is significantly downregulated, ‘switching off’ the dormant signalling to the muscle, so the uterus contracts and initiates labour.

Professor Iain Buxton at the Myometrial Research Group at the University of Nevada said: “Pregnancy is the most impressive example of a human muscle enduring mechanical stress for a prolonged period. Finding Piezo1 in the muscular layer of the uterus means the uterus is controlled locally and is coordinated by a stretch-activated mechanism rather than hormonal influence from the ovaries or the placenta, which has been the assumption.

“It is troubling that there are still no drugs available to stop preterm labour. Thanks to the Nobel Prize winning discovery of Piezo proteins, which are responsible for how the body responds to mechanical force, and our investigation we are now closer to developing a treatment. Piezo1 and its relaxation mechanism provide a target for us which we could potentially activate with drugs. We need to test this with further studies and we hope to carry out clinical trials in the future.”

Contraction and relaxation were assessed in tissue samples compared for the following gestational periods: non-pregnant, term non-labouring, term labouring, preterm non-labouring and preterm labouring. The presence of Piezo1 channels was discovered using molecular tools while pregnant tissues contracting in a muscle bath were stimulated with Piezo1 channel activator and inhibitor to characterize the regulation of quiescence.

More research is needed to understand just how all the molecular signals and steps involved in the Piezo1 channel regulate uterus relaxation, and to identify other chemicals that may be involved.

Source: The Physiological Society

Categories : Obstetrics & Gynaecology PaediatricsTags :

Increased Odds of ADHD Symptoms in Children Born Before 39 Weeks

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Among children born at term (37–41 weeks), those born before 39 weeks are more likely to experience symptoms associated with attention-deficit/hyperactivity disorder (ADHD), according to a study published in the Journal of Pediatrics.

ADHD manifests early in childhood with symptoms of hyperactivity, impulsivity or inattention, and has known links to preterm birth (less than 37 weeks gestation). The present study is one of only a handful to investigate the associations between gestational age at term and a diagnosis or symptoms of ADHD. It is the first to include reports from teachers.

“Teachers’ reports, in conjunction with maternal reports and physician evaluations, provide valuable input for the diagnosis of ADHD,” said study author Nancy Reichman, author of the study and a professor of paediatrics at Rutgers Robert Wood Johnson Medical School. “Mother-reported symptoms generally reflect behaviours in the home or in small family or social groups, while teacher-reported symptoms reflect behaviours in a structured educational setting by professionals who work with a large number of children and observe the range of behaviours that students exhibit in classrooms.”

Prof Reichman and her team set out to estimate the link between gestational age at term and 9-year-old children’s teacher-reported ADHD symptoms.

The team analysed data on about 1400 children in a birth cohort study that randomly sampled births from large US hospitals 1998 to 2000 and re-interviewed mothers over nine years as well as teachers’ evaluations using the Conners’ Teacher Rating Scale-Revised Short Form.

The researchers found that children born early-term (37-38 weeks) had significantly higher scores on the teacher rating scales than children who were full-term (39-41 weeks) for hyperactivity, ADHD and cognitive problems or inattention, but that gestational age wasn’t significantly associated with oppositional behaviour.

Specifically, the researchers found that each week of gestational age at term was associated with 6% lower hyperactivity scores and 5% lower ADHD and cognitive problems or inattention scores, and that birth at 37 to 38 weeks was associated with 23% higher hyperactivity scores and 17% higher ADHD scores when compared with birth at 39 to 41 weeks.

“The findings add to growing evidence supporting current recommendations for delaying elective deliveries to at least 39 weeks and suggest that regular screenings for ADHD symptoms are important for children born at 37 to 38 weeks,” Prof Reichman said.

Preterm infants are at greater risk for ADHD because of immature brain development, she said. “Significant growth and development in various kinds of brain cells are observed between 34 and 40 weeks of gestation,” said Reichman. “Infants born at full-term likely benefit from the additional one to two weeks of brain growth in utero compared with those born early-term.”

Source: Rutgers University

Categories : Environmental Effects Obstetrics & GynaecologyTags :

Maternal Phthalates Exposure Increases Preterm Birth Risk

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pregnant woman holding her belly
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A National Institutes of Health study has found that pregnant women who were exposed to multiple phthalates during pregnancy had an increased risk of preterm birth. The most significant correlation was for a phthalate most commonly used in nail polish and cosmetics.

Used in a great variety of products such as cosmetics and food packaging, phthalates are endocrine-disrupting chemicals that are known to have a wide range of health effects on humans. This especially true of children, due to their impact on the developmental system, as well as the reproductive system.

Researchers analysed data from more than 6000 pregnant women in the US, and found that women with higher concentrations of several phthalate metabolites in their urine had increased risks of preterm birth.

“Having a preterm birth can be dangerous for both baby and mom, so it is important to identify risk factors that could prevent it,” said epidemiologist Kelly Ferguson, PhD, the senior author on the study published in JAMA Pediatrics.

Data from 16 US studies that included individual participant data on prenatal urinary phthalate metabolites (representing exposure to phthalates) as well as the timing of delivery. Researchers analysed data from a total of 6045 pregnant women who delivered between 1983-2018, 9% of whom delivered preterm. Phthalate metabolites were detected in more than 96% of urine samples.

Exposure to four of the 11 phthalates found in the pregnant women was associated with a 14–16% greater probability of having a preterm birth. The most consistent findings were for exposure to a phthalate that is used commonly in personal care products like nail polish and cosmetics.

Using statistical models to simulate interventions that reduce phthalate exposures, the researchers found that reducing the mixture of phthalate metabolite levels by 50% could prevent preterm births by 12% on average. Interventions targeting behaviours, such as trying to select phthalate-free personal care products (if listed on label), voluntary actions from companies to reduce phthalates in their products, or changes in standards and regulations could contribute to exposure reduction and protect pregnancies.

“It is difficult for people to completely eliminate exposure to these chemicals in everyday life, but our results show that even small reductions within a large population could have positive impacts on both mothers and their children,” said Barrett Welch, PhD, first author on the study.

Eating fresh, home-cooked food, avoiding processed food that comes in plastic containers or wrapping, and selecting fragrance-free products or those labeled ‘phthalate-free’, are examples of things people can do that may reduce their exposures. Changes to the amount and types of products that contain phthalates could also reduce exposures.

The researchers are undertaking further studies to better understand the mechanisms behind how phthalates affect pregnancy and to find ways for mothers to reduce their exposures.

Source: National Institutes of Health

Categories : COVID Obstetrics & GynaecologyTags :

COVID Vaccination During Pregnancy Does not Cause Complications

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COVID vaccination during pregnancy is not associated with a higher risk of pregnancy complications, according to a large scale Swedish and Norwegian study published in the journal JAMA.

The study, which comprised almost 160 000 pregnancies, found there to be no increase in the risk of preterm birth, growth retardation, low Apgar scores at birth or the need for neonatal care after vaccination against COVID during pregnancy.

“The results are reassuring and can hopefully make pregnant individuals more willing to get vaccinated,” said co-first author Anne Örtqvist Rosin, researcher at the Department of Medicine, Karolinska Institutet.

Studies have shown that, compared to non-pregnant peers, pregnant women are at risk of serious COVID requiring intensive care with a higher risk of death. Preterm births are also more likely in pregnant women with severe COVID. COVID vaccines have been available in Sweden and Norway since January 2021, and in May 2021 Sweden recommended all pregnant individuals to have a COVID jab, followed in August by Norway.

“We’re still seeing that vaccination rates are lower than in the rest of the population, so it’s likely that there’s some concern about how the vaccines affect the pregnant individual and the foetus,” explained Dr Örtqvist Rosin. “When the vaccines were produced, pregnant women were not included in the large clinical studies, and until now there have been no population-based data about any risk there might be to them.”

The researchers linked Sweden’s Pregnancy Register and Norway’s Medical Birth Register to each country’s vaccination register to obtain data on if and when pregnant individuals were vaccinated and with which vaccine. The study included a total of 157 521 individuals who gave birth between January 2021 and January 2022, of whom 18% had been vaccinated. It was found that vaccinated individuals were at no higher risk than unvaccinated of developing one of the studied complications.

The majority of the pregnant individuals included in the study were vaccinated after week 12 in accordance with current recommendations, and 95% received an mRNA vaccine. This should be factored in when interpreting the results, which were similar for the different mRNA vaccines regardless of whether one or two doses were given. Vaccination during the third trimester and vaccination with the Moderna vaccine was associated with a slightly lower risk of needing neonatal care.

A possible benefit of vaccination during pregnancy is that the antibodies generated pass through the placenta, conferring a certain degree of protection against COVID to the newborn baby.

“We’re now planning to study how long this protection lasts, and if SARS-CoV-2 infection or vaccination during pregnancy has any other lasting effects on the child’s health,” said joint last author Professor Olof Stephansson at the Karolinska Institutet .

Source: Karolinska Institutet

Categories : PaediatricsTags :

Neurodevelopmental Disorders Widespread in Extremely Preterm Babies

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Preterm baby
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An Acta Paediatrica analysis of data for extremely preterm babies (born before 24 weeks) found that most had neurodevelopmental disorders and/or other diagnoses during childhood and were referred for habilitational care.

In the Swedish study of 383 children from 2007 to 2018, 75% had neurodevelopmental disorders (including speech disorders, intellectual disabilities, attention deficit hyperactivity disorder, autism spectrum disorders, visual impairment, cerebral palsy, epilepsy, and hearing impairment).

More boys than girls had intellectual disabilities (45% versus 27%) and visual impairment (25% versus 14%). Fifty-five percent of children were referred for habilitation services, and 88% had additional diagnoses such as asthma and short stature.

“Due to improved medical care, an increasing number of extremely preterm infants survive. Our study shows that a large proportion of the most immature new survivors suffer from persisting somatic and neurodevelopmental disorders,” said senior author Ann Hellström, MD, PhD, of Gothenburg University.

A better understanding of the long-term consequences of preterm birth will assist clinicians and healthcare systems in optimising care. “Awareness of the lifelong needs of these children is also necessary for society at large to provide adequate resources and support for the tiniest of our children and their families,” said lead author Eva Morsing, MD, PhD of Lund University.

Source: Wiley

Categories : PaediatricsTags :

Delayed Umbilical Clamping in Preterm Babies Saves Lives

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A study following the effects of delayed umbilical cord clamping in preterm babies has found significant reduction in subsequent mortality and disability. The findings were published in The Lancet Child and Adolescent Health.

The study was a two-year follow up of the Australian Placental Transfusion Study, the award-winning and largest-ever clinical trial of delayed cord clamping of babies born before 30 weeks. Infants born preterm (before 37 weeks’ gestation) have poorer outcomes than infants at term, especially if born before 32 weeks.

The new study compared outcomes for over 1500 babies from the initial study, 767 with caregivers aiming for 60 second delay in clamping and 764 with caregivers aiming for cord clamping before 10 seconds after delivery.

Researchers found that delaying clamping reduces a child’s relative risk of death or major disability in early childhood by 17%. This included a 30% reduction in mortality  before age two. In addition, 15% fewer infants in the delayed-clamping group needed blood transfusions after birth.

The leader of the study, Professor William Tarnow-Mordi, said the simple process of aiming to wait a minute before clamping will have significant global impact.

“It’s very rare to find an intervention with this sort of impact that is free and requires nothing more sophisticated than a clock. This could significantly contribute to the UN’s Sustainable Development goal to end preventable deaths in newborns and children under five – a goal which has really suffered during the pandemic,” he said.

“Applied consistently worldwide, aiming to wait a minute before cord clamping in very preterm babies who do not require immediate resuscitation could ensure that an extra 50 000 survive without major disability in the next decade,” said biostatistician Dr Kristy Robledo from the University of Sydney who led the two-year follow-up analysis.

“In other words, for every 20 very preterm babies who get delayed instead of immediate clamping, one more will survive without major disability.”

Delayed umbilical cord clamping is routine in full term babies to allow the newborn time to adapt to life outside the womb, however, until recently, clinicians generally cut the cord of preterm babies immediately so urgent medical care could be given.

“Ten years ago, umbilical cords were routinely clamped quickly after a very preterm birth and the baby was passed to a paediatrician in case the child needed urgent help with breathing,” said Professor Tarnow-Mordi.

“But we now know that almost all very preterm babies will start breathing by themselves in the first minute, if they are given that time.”

“We think that, after delaying cord clamping, babies get extra red and white blood cells and stem cells from the placenta, helping to achieve healthy oxygen levels, control infection and repair injured tissue.”

The childhood follow-up to the Australian Placental Transfusion Study is the largest world-wide two-year follow up of preterm cord clamping providing the best evidence so far on positive outcomes at two years of age.

In 2017, a systematic review of randomised trials in nearly 3000 preterm babies provided the first evidence indicating that delayed umbilical cord clamping might have benefits for preterm infants and their mothers.
While the World Health Organization recommends that newborns, including preterm babies who do not require positive pressure ventilation should not have their cord clamped earlier than one minute after birth this has not always been consistently applied.

“Moving forward it’s vital that perinatal professionals record the time of first breath and cord clamping to the second during births to allow for robust, large-scale data to further our work in this area,” said co-author Professor Jonathan Morris.

“Intensive staff training in the new protocols will also be vital as it can be daunting to delay treatment in very early and sick babies, but the evidence suggests this results in the best outcomes for these children.”

Source: University of Sydney

Categories : COVID Obstetrics & GynaecologyTags :

No COVID Impact on Increased Preterm Births or Stillbirths

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A study found no increases in preterm births or stillbirths during the first year of the COVID pandemic, which will help alleviate concerns around pregnancy and COVID. The large study of more than 2.4 million births in Ontario is published in CMAJ (Canadian Medical Association Journal).

Infection, inflammation, stress, medical or pregnancy-induced disorders, genetic predisposition, and environmental factors are risk factors for stillbirth and preterm birth, although in many instances the exact mechanism is not yet known.

During the COVID pandemic, reports emerged of declining rates of preterm births in countries such as the Netherlands, Ireland and the United States, while the United Kingdom, Italy, India while others reported increases in stillbirths and some variability in preterm birth rates. However, most studies were limited by their small size.

To identify a possible shift, the study researchers analysed Ontario births over an 18-year period and compared these trends in the prepandemic period (2002–2019) with the pandemic period (January to December 2020).

“We found no unusual changes in rates of preterm birth or stillbirth during the pandemic, which is reassuring,” said Dr Prakesh Shah, a paediatrician-in-chief at Sinai Health and professor at University of Toronto, Toronto, Ontario.

It is possible that measures related to the pandemic and compliance with them could affect preterm birth rates in different settings. Thus, the researchers examined birth outcomes in the public health units with higher SARS-CoV-2 positivity rates (Toronto, Peel Region, York Region and Ottawa), and also compared urban and rural births and those in neighbourhoods with different average income levels.

“In some areas and in certain people, the restrictions could be beneficial, and in other settings or individuals, restrictions could have the opposite effect,” said Dr Shah.  

International studies are now underway to help understand the impact of COVID on pregnancy and childbirth around the globe.

Source: EurekAlert!

Categories : Hospitals Obstetrics & GynaecologyTags :

Breakthrough AI Development for Premature Baby Care

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Researchers believe they have made a breakthrough in the science of keeping premature babies alive.

As part of her PhD work, James Cook University engineering lecturer Stephanie Baker led a pilot study that used a hybrid neural network to accurately predict how much risk individual premature babies face. This study was published in the journal Computers in Biology and Medicine.

Complications resulting from premature birth are the leading cause of death in children under five and over 50% of neonatal deaths occur in preterm infants, she said. In 2005, 12.9 million births, or 9.6% of all births worldwide, were preterm.

“Preterm birth rates are increasing almost everywhere. In neonatal intensive care units, assessment of mortality risk assists in making difficult decisions regarding which treatments should be used and if and when treatments are working effectively,” said Ms Baker.

To better guide their care, preterm babies are often given a score that indicates the risk they face.

“But there are several limitations of this system. Generating the score requires complex manual measurements, extensive laboratory results, and the listing of maternal characteristics and existing conditions,” noted Ms Baker.

She said the alternative was to measure variables that do not change (eg, birthweight) that prevents recalculation of the infant’s risk on an ongoing basis and does not show their response to treatment.

“An ideal scheme would be one that uses fundamental demographics and routinely measured vital signs to provide continuous assessment. This would allow for assessment of changing risk without placing unreasonable additional burden on healthcare staff,” said Ms Baker.

She said the JCU team’s research had culminated in the Neonatal Artificial Intelligence Mortality Score (NAIMS), a hybrid neural network that relies on simple demographics and trends in heart and respiratory rate to determine mortality risk.

“Using data generated over a 12 hour period, NAIMS showed strong performance in predicting an infant’s risk of mortality within 3, 7, or 14 days.

“This is the first work we’re aware of that uses only easy-to-record demographics and respiratory rate and heart rate data to produce an accurate prediction of immediate mortality risk,” said Ms Baker.

According to Ms Baker, the technique was fast with no invasive procedures or knowledge of medical histories needed.

“Due to the simplicity and high performance of our proposed scheme, NAIMS could easily be continuously and automatically recalculated, enabling analysis of a baby’s responsiveness to treatment and other health trends,” said Ms Baker.

She said NAIMS had proved accurate when tested against hospital mortality records of preterm babies and had the added advantage over existing schemes of being able to perform a risk assessment based on any 12 hour period of data gathered during the patient’s stay.

Ms Baker said the next step in the process was partnering with local hospitals to gather more data and undertake further testing.

“Additionally, we aim to conduct research into the prediction of other outcomes in neo-natal intensive care, such as the onset of sepsis and patient length of stay,” said Ms Baker.

Source: James Cook University

Journal information: Baker, S., et al. (2021) Hybridized neural networks for non-invasive and continuous mortality risk assessment in neonates. Computers in Biology and Medicine. doi.org/10.1016/j.compbiomed.2021.104521.