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

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-< 48 h are eligible. Treatment allocation is random in a 1:1 ratio between groups, stratified by weight and recruitment site. The primary outcome is mortality within seven days. Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days. Primary analyses will be by intention-to-treat. Quantitative and qualitative data will be integrated in a process evaluation. Cost data will be collected and used in economic modelling.

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.

Keywords: Kangaroo care; Low birthweight; Neonatal mortality; Newborn; Pragmatic; Preterm; Randomised controlled trial; Skin-to-skin contact.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1

Map of Uganda showing location of the four OMWaNA trial hospitals. Source of map data: Google Maps©, 2019

Fig. 2

OMWaNA trial schedule of enrolment, interventions and assessments 1. The start of trial procedures (time 0) is defined as when the pulse oximeter is attached for cardio-respiratory monitoring 2. All participants are reviewed daily while admitted to the hospital 3. All participants receive continuous monitoring of heart rate (HR) and oxygen saturation (SpO2) for 72 h after randomisation. Continuous monitoring continues until participants no longer require any form of respiratory support 4. HR, SpO2, axillary temperature and respiratory rate are measured every 6 h until stability criteria are met, after which the frequency transitions to daily 5. Blood glucose is measured daily and may be discontinued once the participant tolerates full enteral feeds 6. Participants are weighed on day 5, then daily until discharge (unless deemed too unstable by site study staff) 7. Socioeconomic data, including household details, are collected within 48 h of enrolment. During this time, study staff also inform families that they will be asked about their household expenditures and activities over the coming month 8. For participants at Entebbe and Jinja Hospitals, cranial ultrasounds are performed on days 1, 3 and 7 of hospitalisation (or as an outpatient if discharged before day 7) and on follow-up at day 28–30 9. The Women’s Capabilities Index (WCI) is administered to all mothers within 48 h of enrolment and on days 28–30 to assess women’s wellbeing 10. The Maternal Infant Responsiveness Instrument (MIRI) is administered on days 28–30 to assess infant-caregiver attachment 11. Duration of admission is measured as the mean time (days and hours) from hospital admission to discharge

Fig. 3

Overview of trial flow including routine procedures and key criteria for eligibility screening, assessing severe illness and stopping KMC 1. Refusal to feed, feed intolerance or abdominal distension (after starting feeds) 2. Increased respiratory support defined as new oxygen or CPAP requirement 3. Axillary temperature < 35.5°C after 1 h of observed skin-to-skin contact, not associated with environment or with hypoglycaemia 4. For participants at EH and JH, cranial ultrasounds will be performed on days 1, 3 and 7 of hospitalisation (or as an outpatient if discharged before day 7) and on follow-up at days 28–30. CPAP continuous positive airway pressure, EH Entebbe Hospital, HC head circumference, JH Jinja Hospital. a Screening for eligibility. b Signs of severe illness. c Suspected infection criteria. d Criteria for stopping KMC

Fig. 4

OMWaNA intervention (KMC) and control (standard incubator care) arms. Images: University of California San Francisco Preterm Birth Initiative, with caregiver consent for publication (a); Melissa Medvedev (b)

Fig. 5

Study site participant flow for the OMWaNA trial. Inc incubator, RH radiant heater

Fig. 6

CONSORT flow diagram for the OMWaNA trial