Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa

NCT02811432 | Completed Results DMC

• 1 other identifier: 0
• Study Type: interventional
• Target: 2,221
• Locations: 1 country
• Sites: 4

Brief Summary

We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care. The primary aim is to examine the impact of KMC initiated before stabilisation on mortality within 7 days relative to standard care amongst neonates ≤2000g at four hospitals in Uganda. We hypothesise that neonates in the arm allocated to receive KMC before stabilisation will have a 25% overall reduction in mortality within 7 days compared to neonates allocated to receive standard care.

Conditions

Kangaroo Mother Care; Preterm Infant; Death; Neonatal; Hypothermia, Newborn

Keywords

Kangaroo mother care; Preterm; Low birthweight; Neonatal; Newborn; Randomised trial

Outcome Measures

Primary Outcomes (1)

• Mortality Within 7 Days

  early neonatal mortality at 7 days

  7 days

Secondary Outcomes (10)

• Prevalence of Hypothermia at 24 Hours Post-randomisation

  24 hours

• Time From Intervention/Control Procedures Starting to Clinical Stabilisation

  30 days

• Time From Starting Intervention/Control Procedures to Death

  30 days

• Mean Duration of Hospital Stay in Days

  30 days

• Proportion of Neonates Exclusively Breastmilk Feeding at Discharge

  30 days

Study Arms (2)

Kangaroo mother care

EXPERIMENTAL

Skin-to-skin care initiated as soon as possible following randomisation

Other: Kangaroo mother care

Standard care

ACTIVE COMPARATOR

Incubator or radiant warmer

Other: Standard care

Interventions

Standard care OTHER

Incubator or radiant warmer until neonate meets stability criteria; once stable (WHO indication for KMC certain), the baby can transition to routine (intermittent) KMC

Standard care

Kangaroo mother care OTHER

Skin-to-skin care (target: at least 18 hours per day)

Also known as: Skin-to-skin care

Kangaroo mother care

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Liveborn at Jinja Hospital, Masaka Hospital, Entebbe Hospital, or Iganga Hospital
• Singleton or twin pregnancy
• Birthweight ≥700g and ≤2000g
• Chronological age 1-48 hours at time of screening
• Alive at time of recruitment
• Parent/caregiver able and willing to provide KMC
• Parent/caregiver willing to attend follow-up visit
• Indication for KMC "uncertain" according to WHO guideline concerning clinical stability: pragmatically defined as receiving ≥1 therapy: oxygen, CPAP, IV fluids, therapeutic antibiotics, phenobarbital

You may not qualify if:

• Outborn
• Result of triplet or higher order multifetal pregnancy
• Indication for KMC "certain" according to WHO guidelines: pragmatically defined as clinically well neonates receiving none of the above therapy-based criteria
• Severely life-threatening instability defined as SpO2 \<88% in oxygen AND ≥1 of:
• Respiratory rate \<20 or \>100 breaths/min
• Apnoea requiring bag-mask ventilation
• HR \<100 or \>200 bpm
• Severe jaundice requiring immediate management
• Active neonatal seizures
• Major congenital malformation
• Parent does not provide written informed consent to participate in trial
• Mother or neonate enrolled in another MRC/UVRI research project

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• Makerere University: collaborator

Study Sites (4)

Entebbe

Entebbe, Uganda

Location

Iganga District Hospital

Iganga, Uganda

Location

Jinja Regional Referral Hospital

Jinja, Uganda

Location

Masaka Regional Referral Hospital

Masaka, Uganda

Location

Related Publications (3)

• Medvedev MM, Tumukunde V, Mambule I, Tann CJ, Waiswa P, Canter RR, Hansen CH, Ekirapa-Kiracho E, Katumba K, Pitt C, Greco G, Brotherton H, Elbourne D, Seeley J, Nyirenda M, Allen E, Lawn JE. Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda. Trials. 2020 Jan 31;21(1):126. doi: 10.1186/s13063-019-4044-6.

  PMID: 32005286 BACKGROUND

• Medvedev MM, Tumukunde V, Kirabo-Nagemi C, Greco G, Mambule I, Katumba K, Waiswa P, Tann CJ, Elbourne D, Allen E, Ekirapa-Kiracho E, Pitt C, Lawn JE. Process and costs for readiness to safely implement immediate kangaroo mother care: a mixed methods evaluation from the OMWaNA trial at five hospitals in Uganda. BMC Health Serv Res. 2023 Jun 10;23(1):613. doi: 10.1186/s12913-023-09624-z.

  PMID: 37301974 BACKGROUND

• Tumukunde V, Medvedev MM, Tann CJ, Mambule I, Pitt C, Opondo C, Kakande A, Canter R, Haroon Y, Kirabo-Nagemi C, Abaasa A, Okot W, Katongole F, Ssenyonga R, Niombi N, Nanyunja C, Elbourne D, Greco G, Ekirapa-Kiracho E, Nyirenda M, Allen E, Waiswa P, Lawn JE; OMWaNA Collaborative Authorship Group. Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation. Lancet. 2024 Jun 8;403(10443):2520-2532. doi: 10.1016/S0140-6736(24)00064-3. Epub 2024 May 13.

  PMID: 38754454 RESULT

MeSH Terms

Conditions

Premature Birth; Perinatal Death; Hypothermia

Interventions

Kangaroo-Mother Care Method; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Professor Joy Lawn
• Organization: London Sch Hygiene & Trop Medicine -

joy.lawn@lshtm.ac.uk

+44 (0)20 7636 8636

Study Officials

• Joy E. Lawn, BMBS MPH PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking of parents, caregivers, or healthcare workers was not possible due to the nature of the KMC intervention. The independent statistician who conducted the analyses was masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: October 13, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When main results paper is published - currently under review
• Access Criteria: email to LSHTM data compass and agreement by study data sharing committee

Locations

UG (4)