학술논문

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
Document Type
article
Source
Trials. 21(1)
Subject
Paediatrics
Biomedical and Clinical Sciences
Cost Effectiveness Research
Clinical Research
Comparative Effectiveness Research
Pediatric
Infant Mortality
Clinical Trials and Supportive Activities
6.1 Pharmaceuticals
Evaluation of treatments and therapeutic interventions
Good Health and Well Being
Critical Pathways
Female
Hospitalization
Humans
Infant
Infant Care
Infant
Low Birth Weight
Infant
Newborn
Kangaroo-Mother Care Method
Male
Multicenter Studies as Topic
Outcome Assessment
Health Care
Survival Analysis
Uganda
Weight Gain
Preterm
Low birthweight
Newborn
Kangaroo care
Skin-to-skin contact
Neonatal mortality
Randomised controlled trial
Pragmatic
Cardiorespiratory Medicine and Haematology
Clinical Sciences
Cardiovascular System & Hematology
General & Internal Medicine
Clinical sciences
Epidemiology
Health services and systems
Language
Abstract
BackgroundThere 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.MethodsWe 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-