OMWaNA Trial – Dr. Melissa Medvedev
Dr Melissa Medvedev is an Assistant Professor of Neonatology at UCSF and a Clinical Research Fellow at LSHTM. She is Co-PI of the OMWaNA (Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa) clinical trial, hosted at the Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit (MRCU), undertaken in collaboration with LSHTM and Makerere University.
Currently, for every 1000 live births in Uganda, 20 will die. This is 32,000 newborn deaths annually, with a majority occurring in those who are born small due to being preterm, small-for-gestational age, or both.
OMWaNA is a randomised controlled trial of more than 2000 mothers and their babies across four Ugandan government hospitals – Entebbe, Jinja, and Masaka Regional Referral Hospitals, and Iganga District Hospital. To be eligible, the babies must weigh 2000 grams or less and be less than 48 hours old. Most importantly, they will be too sick to be eligible for KMC according to current guidelines, defined as receiving one or more therapies such as oxygen.
A nurse puts warm knitted hats on twins who are being giving kangaroo mother care by their mother in Uganda. Photo courtesy of the UCSF Preterm Birth Initiative and Makerere School of Public Health, Uganda.
Our aim is to find out if initiating KMC before a preterm baby has stabilised can reduce the number of deaths compared with standard care. Beyond this, we will be exploring the pathways for the intervention’s effects and understanding the cost-effectiveness of KMC compared to standard care – an essential measure for scalable and sustainable interventions in low-income settings.
In particular, we are studying the number of deaths up to seven days following birth, but we also want to know if KMC can reduce deaths up to 28 days, while also collecting data on other important outcomes like admission duration, hypothermia, infant-caregiver attachment, and maternal wellbeing.
With such a large trial, we run small pilots to understand any challenges before rolling out more widely, which can maximise our chance of success and ensure high ethical standards at all times. We have already discovered two major challenges in 2019.
First, obtaining timely informed consent is tricky given the involvement of sick newborns. KMC needs to be started as soon as possible after birth, but some women may be too ill to provide consent or participate, especially within the first 24 hours. It is already a stressful and scary time for parents, particularly in LMIC settings, where knowledge of preterm birth is generally low and complications are not always anticipated.
Secondly, although KMC is a fairly simple intervention, asking caregivers to maintain skin-to-skin contact for more than 18 hours a day is difficult and can lead to low adherence. We provide an illustrated handout and counsel them about the benefits of KMC throughout the hospital stay, but found that lack of privacy and inadequate space for beds and equipment were significant barriers.
By understanding these challenges in advance, we have been able to implement solutions.
A continuous consent approach, providing information multiple times before and after recruitment.
Sensitisation programmes to raise awareness about both KMC and the trial across the four hospitals, surrounding antenatal clinics, and major referral centres.
Provision of KMC wraps in each unit, and a provision of increased space in the neonatal units may facilitate privacy and hopefully improve safe and effective care.
The future establishment of KMC peer-counselling programmes at each trial hospital, enlisting mothers who practiced KMC when they return for follow-up.
A mother of twins provides kangaroo mother care in Uganda. Photo courtesy of the UCSF Preterm Birth Initiative and Makerere School of Public Health, Uganda.
Over the six months preceding the start of the trial, we have also made extensive efforts to expand neonatal care capacity at each hospital. We have been making infrastructure and equipment changes to ensure the safe care of all newborns, whether in the trial or not. For example, KMC areas within the neonatal units have been expanded; additional sinks, bathrooms, and office space have been installed; and medical supplies like oxygen concentrators, adjustable beds, pulse oximeters, and ventilation bags and masks were provided.
Despite these efforts, resource constraints are inevitable. Supply and medication shortages are common in these hospitals and repair of malfunctioning equipment is often delayed. While consistent power is required for incubators, radiant warmers, oxygen concentrators, and phototherapy units, the trial hospitals do occasionally experience brief power outages. To understand the scale of the problem, we’ll be surveying staff every 4 months over the course of the trial to capture data as part of the process evaluation.
With rates of preterm birth rising or stagnant across the globe, finding ways to improve survival and reduce disability in preterm babies in the highest risk settings is a growing imperative. OMWaNA is striving to find out if KMC can benefit this vulnerable population. Trial results are expected in mid-2022.
Members of the OMWaNA team conducting a kangaroo mother care training challenge.
The OMWaNA trial is funded by the Joint Global Health Trials scheme of the Medical Research Council, Wellcome Trust, Department for International Development, and Department of Health and Social Care. Trial results are expected in mid-2022 and more information can be found at clinicaltrials.gov, NCT02811432.