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

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.

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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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.

Inclusion Criteria:

• New admission to study site during study period
• Admission weight <2000g
• Age 1 - 24h at start of screening
• Alive at enrolment
• Availability of study bed
• Written informed consent from parent or caregiver
• Parent or caregiver available and willing to provide intervention, if necessary

Exclusion Criteria:

• Congenital malformation incompatible with life or needing immediate surgical correction
• Severe jaundice needing immediate management
• Seizures
• Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring
• Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring
• Completed triplet admission
• Mother and/or neonate enrolled in another research study at time of hospital admission