Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

London School of Hygiene and Tropical Medicine279 enrolled

Overview

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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

279

Conditions

Eligibility

Sex: ALLMin age: 1 HourMax age: 24 Hours

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

All-cause Mortality

All neonatal deaths within 28 postnatal days

Time frame: 28 days

Secondary Outcomes

Time to Death

Time from start of intervention/control procedures to death

Time frame: 28 days of age

Cardio-respiratory Stability

The 'Stability of Cardio-Respiratory in Preterm' infants is a scale to quantify the cardio-respiratory stability of preterm infants. It is composed of three parameters: Heart rate; Respiratory rate and breathing pattern and oxygen saturation (including whether is in oxygen). Scores between 0 and 2 are allocated for each parameter, with minimum total score 0 and maximum total score 6. The highest score (6) represents a better outcome, with all parameters within normal range whilst not receiving oxygen.

Time frame: At 24 hours after start of intervention/control procedures

Number and Proportion of Participants With Hypothermia

Number and proportion of participants with hypothermia (Temperature \<36.5 degrees Celsius)

Time frame: At 24 hours after start of intervention/control procedures

Weight Gain

Average daily weight gain compared to admission weight

Time frame: At 28 days of age

Exclusive Breastfeeding

Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation)

Time frame: At time of hospital discharge, within study period, on average 2 weeks of age

Suspected Infection Between 3d to 28d of Age

Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up

Time frame: Within 28 days of age

Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae

Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae

Time frame: At day 28 of age

Duration of Hospital Admission

Mean length of admission (first admission only if re-admitted)

Time frame: Within 28 days of age or at latest follow-up