NCT03555981

Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

Summary

The mortality effect of kangaroo mother care in stable newborns \<2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates \<2000g in a resource limited hospital setting.

Detailed description

This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates \<2000g and aged \<24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at \<24h of admission) or standard care with continuous KMC at \>24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms. Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.

Conditions

• Preterm Infant
• Hypothermia, Newborn
• Death
• Kangaroo Mother Care
• Infection, Bacterial

Interventions

Type	Name	Description
OTHER	Early Kangaroo Mother Care	Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission
OTHER	Standard care	Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care

Timeline

• Start date: 2018-05-20
• Primary completion: 2020-04-20
• Completion: 2020-04-20
• First posted: 2018-06-14
• Last updated: 2026-04-16
• Results posted: 2023-10-16

Locations

1 site across 1 country: The Gambia