N/A
N=2,221
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
Kangaroo Mother Care · Preterm Infant · Death; Neonatal · Hypothermia, Newborn
Bottom Line
View on ClinicalTrials.gov: NCT02811432 ↗Enrolled (actual)
2,221
Serious AEs
11.9%
Results posted
Jan 2026
Primary outcome: Primary: Mortality Within 7 Days — 81; 83 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kangaroo mother care (Other); Standard care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- London School of Hygiene and Tropical Medicine
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality Within 7 Days |
81; 83 | — |
| SECONDARY Prevalence of Hypothermia at 24 Hours Post-randomisation |
448; 585 | — |
| SECONDARY Time From Intervention/Control Procedures Starting to Clinical Stabilisation |
5.1; 4.9 | — |
| SECONDARY Time From Starting Intervention/Control Procedures to Death |
5.0; 5.9 | — |
| SECONDARY Mean Duration of Hospital Stay in Days |
7.3; 6.1 | — |
| SECONDARY Proportion of Neonates Exclusively Breastmilk Feeding at Discharge |
959; 978 | — |
| SECONDARY Mortality Within 28 Days |
119; 134 | — |
| SECONDARY Frequency of Readmission |
0.02; 0.04 | — |
| SECONDARY Daily Weight Gain at 28 Days |
7.8; 7.1 | — |
| SECONDARY Infant-caregiver Attachment at 28 Days |
85.4; 85.0 | — |
| SECONDARY Women's Well-being at 28 Days |
0.69; 0.68 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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 100 breaths/min
- Apnoea requiring bag-mask ventilation
- HR 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
Data sourced from ClinicalTrials.gov (NCT02811432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.