Emollient therapy for very low birthweight infants (<1500g) in Uganda: effects on survival, infection, growth and development

Imagine this: Every year, 15 million babies are born "too soon," or preterm, and more than 70% of them are born in places like sub-Saharan Africa and South Asia. These tiny tots face a big problem – being born too early is a major cause of death for children under 5 years old all around the world. Here's the deal: Some of these ‘preemies’ are even smaller, weighing less than 1500 grams, which makes them very vulnerable. They have delicate skin that loses water and heat easily, and they're more likely to become infected and sick. That's why we're turning to a simple yet promising solution – applying sunflower seed oil (SSO) to their skin. Earlier studies in South Asia show that applying this oil on the skin of these tiny babies might help them avoid infections, grow better, develop normally, and even survive. The World Health Organization (WHO) wants to know more and have asked: "What happens when we use emollients, like SSO, on these preterm or low birthweight (LBW) babies in different countries, especially in Africa?" So, here's the plan: We're going to conduct a study in eastern Uganda. We will compare the outcome with and without SSO and see if this can lower the number of babies who pass away in the hospital by 25% in the first 28 days after birth by using the oil. Here's how it'll work: We'll randomise 1206 infants weighing less than 1500 grams into two groups. One group will get the SSO treatment three times a day for the first 28 days, and the other will receive regular care. We'll keep a close eye on them to see how they do. We want to know if the SSO can lower the chances of serious infections, help them grow, make them smarter, and most importantly, help them make it to their first birthday. In simpler terms, we're testing if this simple oil can be a lifesaver for the tiniest among us and our mission is to find out for sure.

Background: Approximately 15 million infants are born ‘too soon’ (preterm) every year – over 70% of them in sub-Saharan Africa (SSA) and South Asia. Globally, complications of being born preterm account for the greatest number of deaths in children <5 years. Data suggest that 30% of neonatal deaths occur in very low birthweight (VLBW) infants (<1500g) in SSA and Asia. VLBW infants have immature skin, resulting in water and heat loss, and a risk of pathogens entering. And they are prone to infections, death and impaired growth and neurodevelopment. Emollient therapy (topical skin barrier therapy) with sunflower seed oil (SSO) is a potential intervention to reduce infections and improve growth, development and survival. Preliminary studies from South Asia indicate that topical application of emollients, such as SSO, to the skin of VLBW infants may improve outcomes. This has prompted World Health Organization (WHO) to list the following as a priority research question: “What is the effect of emollients on mortality, sepsis, growth, thermo-protection, microbiome, and longer-term neurodevelopment of preterm or LBW infants in high-income, middle-income, and low-income countries, especially in Africa?” We propose to respond to this question by undertaking a randomized controlled trial of this low-cost intervention in eastern Uganda. The trial has been co-created in close collaboration with parents to VLBW infants, representatives of end-users. Hypothesis and aim: Emollient therapy with SSO among VLBW infants will reduce in-hospital mortality up to day 28 by 25% compared to infants who receive standard-of-care. Study design: In a randomized controlled trial, 1206 VLBW neonates will be randomized 1:1 to either intervention or comparator arm. Emollient therapy will be applied 3 times daily while hospitalized up to day 28 after birth. Participants will be compared for incidence of serious bacterial infections, survival, growth, and neurodevelopment and followed up to 1 year