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

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.

Study Overview

• Status: Terminated
• Conditions: Death; Infection, Bacterial; Preterm Infant; Hypothermia, Newborn; Kangaroo Mother Care
• Intervention / Treatment: Other: Early Kangaroo Mother Care; Other: Standard care

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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Gambia
  • Western Division
    • Fajara, Western Division, Gambia
      • MRC Unit The Gambia at LSHTM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 day (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early KMC; 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	Other: Early Kangaroo Mother Care; Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission; Other Names: Early skin-to-skin contact; Early kangaroo method
Active Comparator: Standard care; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	All neonatal deaths within 28 postnatal days	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Death	Time from start of intervention/control procedures to death	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.	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)	At 24 hours after start of intervention/control procedures
Weight Gain	Average daily weight gain compared to admission weight	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)	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	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	At day 28 of age
Duration of Hospital Admission	Mean length of admission (first admission only if re-admitted)	Within 28 days of age or at latest follow-up

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Wellcome Trust; Medical Research Council Unit, The Gambia
• Investigators: Principal Investigator: Helen C Brotherton, MBChB, London School of Hygiene and Tropical Medicine

Publications and helpful links

General Publications

• Brotherton H, Gai A, Kebbeh B, Njie Y, Walker G, Muhammad AK, Darboe S, Jallow M, Ceesay B, Samateh AL, Tann CJ, Cousens S, Roca A, Lawn JE. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial. EClinicalMedicine. 2021 Aug 6;39:101050. doi: 10.1016/j.eclinm.2021.101050. eCollection 2021 Sep.
• Brotherton H, Gai A, Tann CJ, Samateh AL, Seale AC, Zaman SMA, Cousens S, Roca A, Lawn JE. Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC). Trials. 2020 Mar 6;21(1):247. doi: 10.1186/s13063-020-4149-y.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2018
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Body Temperature Changes; Bacterial Infections; Hypothermia
• Other Study ID Numbers: 14545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No