Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates (eKMC)

London School of Hygiene and Tropical Medicine

Status: Terminated

Conditions: Death; Preterm Infant; Hypothermia, Newborn; Infection, Bacterial; Kangaroo Mother Care

Treatments: Other: Early Kangaroo Mother Care; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03555981

14545

Details and patient eligibility

About

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.

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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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

Enrollment: 279 patients

Sex: All

Ages: 1 to 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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279 participants in 2 patient groups

Early KMC

Experimental group

Description:

Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home

Treatment:

Other: Early Kangaroo Mother Care

Standard care

Active Comparator group

Description:

Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home

Treatment:

Other: Standard care