Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

NCT03555981 | Terminated Results DMC

• 1 other identifier: 14545
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  All neonatal deaths within 28 postnatal days

  28 days

Secondary Outcomes (8)

• Time to Death

  28 days of age

• Cardio-respiratory Stability

  At 24 hours after start of intervention/control procedures

• Number and Proportion of Participants With Hypothermia

  At 24 hours after start of intervention/control procedures

• Weight Gain

  At 28 days of age

• Exclusive Breastfeeding

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

Study Arms (2)

Early KMC

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

Early Kangaroo Mother Care OTHER

Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission

Also known as: Early skin-to-skin contact, Early kangaroo method

Early KMC

Standard care OTHER

Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care

Standard care

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Wellcome Trust: collaborator
• Medical Research Council Unit, The Gambia: collaborator

Study Sites (1)

MRC Unit The Gambia at LSHTM

Fajara, West Coast, The Gambia

Location

Related Publications (2)

• 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.

  PMID: 34401686 DERIVED

• 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.

  PMID: 32143737 DERIVED

MeSH Terms

Conditions

Premature Birth; Hypothermia; Death; Bacterial Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr Helen Brotherton
• Organization: London School of Hygiene & Tropical Medicine

helen.brotherton@lshtm.ac.uk

07481474150

Study Officials

• Helen C Brotherton, MBChB

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individually randomised controlled superiority trial

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 14, 2018
• Study Start: May 20, 2018
• Primary Completion: April 20, 2020
• Study Completion: April 20, 2020
• Last Updated: April 16, 2026
• Results First Posted: October 16, 2023

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)