OMWaNA Operationalising kangaroo Mother care before stabilisation among low birth Weight Neonates in Africa: RCT to examine mortality impact in Uganda

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Globally, there are 2.6 million neonatal deaths each year (defined as death during the first 28 days) and over 80% of these deaths occur in babies who are born small, due to being born too soon (preterm), being too small for their gestational age, or both. Preterm birth complications are the most common cause of death for children under age five worldwide, and yet there has been much slower progress in reducing these deaths compared to child deaths from malaria or HIV. Three-quarters of deaths due to prematurity occur in sub-Saharan Africa and south Asia, where there is limited availability of neonatal intensive care and most hospitals lack basic equipment. In Uganda alone, an estimated 45,000 newborn deaths occur annually, at least a quarter of which are directly due to complications of prematurity.Kangaroo Mother Care (KMC) involves placing the baby skin-to-skin with a caregiver, usually the mother, promoting warmth and breastfeeding and also empowering the mother, increasing maternal confidence to improve bonding with the baby. KMC has been found to reduce deaths by 40% for newborns weighing less than 2000g, but these trials included only babies that were considered to be stable. WHO guidelines recommend KMC for babies weighing 2000g or less at birth, starting as soon as they are 'stable,' i.e., not on any other medical treatments. However, the majority of deaths occur in babies before they have stabilised, with complications like breathing difficulties, soon after birth and in settings without neonatal intensive care. The only randomised controlled trial of KMC on survival amongst babies before stabilisation reported a 43% mortality reduction compared to standard care (incubators). Importantly, this trial excluded over half of eligible babies and had other design problems. Hence, there is currently not enough evidence to recommend KMC for small babies before stabilisation who could benefit the most. A well-designed trial is needed to assess the impact of KMC started before stabilisation on mortality compared to incubator care. The Operationalising kangaroo Mother care before stabilisation among low birth Weight Neonates in Africa (OMWaNA) trial is a partnership of the Medical Research Council Uganda, Makerere University, and the London School of Hygiene and Tropical Medicine. Omwana means 'child' in Uganda's national language. The aim of this trial is to determine the impact of KMC, started before stabilisation, on mortality (at 7 and 28 days) compared to incubator care in a group of babies weighing 2000g or less. In the trial, 2188 babies who are not yet stable will be assigned by chance to receive either KMC or incubator care. The trial will take place in four "typical" hospitals without intensive care (Jinja, Masaka, Iganga, Entebbe). Incubators are the standard method of keeping small and preterm babies warm in Ugandan hospitals, often with several newborns sharing. The trial will also compare the overall costs of KMC and incubator care, considering both costs to hospitals and costs to families. With parents and hospital staff, we will evaluate issues that support or discourage starting KMC before stabilisation. In addition, we will measure quality of life among women caring for small babies in Uganda with a new survey tool. The Ugandan Government committed to meeting an ambitious global goal for newborn survival and has given high priority to addressing newborn deaths. The National Newborn Steering Committee has recommended increased scale-up of KMC in health facilities. Key stakeholders will be engaged throughout the trial including the Uganda Ministry of Health, Uganda Paediatric Association, UNICEF (headquarters and country), WHO, and the International KMC Network. The findings of this trial will help inform wider use of KMC in Uganda and around the world, especially in settings where most babies die, and where neonatal intensive care is not available.