1. Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda
- Author
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Diana Elbourne, Catherine Pitt, Elizabeth Allen, Kenneth R. Katumba, Melissa M Medvedev, Moffat J. Nyirenda, Giulia Greco, Christian Holm Hansen, Cally J Tann, Peter Waiswa, Ruth R. Canter, Victor Tumukunde, Helen Brotherton, Janet Seeley, Ivan Mambule, Elizabeth Ekirapa-Kiracho, and Joy E Lawn
- Subjects
Male ,Comparative Effectiveness Research ,Outcome Assessment ,Medicine (miscellaneous) ,Cardiorespiratory Medicine and Haematology ,Weight Gain ,law.invention ,Study Protocol ,0302 clinical medicine ,Superiority Trial ,Randomized controlled trial ,law ,Outcome Assessment, Health Care ,Infant Mortality ,Multicenter Studies as Topic ,Pharmacology (medical) ,Uganda ,030212 general & internal medicine ,Randomised controlled trial ,Pediatric ,lcsh:R5-920 ,Kangaroo care ,030219 obstetrics & reproductive medicine ,3. Good health ,Hospitalization ,6.1 Pharmaceuticals ,Critical Pathways ,Female ,medicine.symptom ,lcsh:Medicine (General) ,Pragmatic ,medicine.medical_specialty ,Skin-to-skin contact ,Low birthweight ,Clinical Trials and Supportive Activities ,Clinical Sciences ,03 medical and health sciences ,Preterm ,Clinical Research ,Intervention (counseling) ,General & Internal Medicine ,medicine ,Humans ,Neonatal mortality ,Protocol (science) ,business.industry ,Infant, Newborn ,Low Birth Weight ,Infant ,Evaluation of treatments and therapeutic interventions ,Infant, Low Birth Weight ,Newborn ,Kangaroo-Mother Care ,Survival Analysis ,Kangaroo-Mother Care Method ,Health Care ,Low birth weight ,Good Health and Well Being ,Cost Effectiveness Research ,Cardiovascular System & Hematology ,Emergency medicine ,Infant Care ,business ,Weight gain - Abstract
Background There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in stabilised neonates; however, data on its effect among neonates before stabilisation are lacking. The OMWaNA trial aims to determine the effect of initiating KMC before stabilisation on mortality within seven days relative to standard care. Secondary objectives include exploring pathways for the intervention’s effects and assessing incremental costs and cost-effectiveness between arms. Methods We will conduct a four-centre, open-label, individually randomised, superiority trial in Uganda with two parallel groups: an intervention arm allocated to receive KMC and a control arm receiving standard care. We will enrol 2188 neonates (1094 per arm) for whom the indication for KMC is ‘uncertain’, defined as receiving ≥ 1 therapy (e.g. oxygen). Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥ 1 baby) weighing ≥ 700–≤ 2000 g and aged ≥ 1– Discussion The OMWaNA trial aims to assess the effectiveness of KMC in reducing mortality among neonates before stabilisation, a vulnerable population for whom its benefits are uncertain. The trial will improve understanding of pathways underlying the intervention’s effects and will be among the first to rigorously compare the incremental cost and cost-effectiveness of KMC relative to standard care. The findings are expected to have broad applicability to hospitals in sub-Saharan Africa and southern Asia, where three-quarters of global newborn deaths occur, as well as important policy and programme implications. Trial registration ClinicalTrials.gov, NCT02811432. Registered on 23 June 2016.
- Published
- 2020