Status:
COMPLETED
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
MRC/UVRI and LSHTM Uganda Research Unit
Makerere University
Conditions:
Kangaroo Mother Care
Preterm Infant
Eligibility:
All Genders
1-48 years
Phase:
NA
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 primar...
Detailed Description
METHODS Study setting, design, and participants The OMWaNA trial was an individually randomised, controlled, superiority trial with two parallel arms allocated in a 1:1 ratio to receive KMC initiated ...
Eligibility Criteria
Inclusion
- 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 \<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
Exclusion
Key Trial Info
Start Date :
October 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
2221 Patients enrolled
Trial Details
Trial ID
NCT02811432
Start Date
October 13 2019
End Date
September 30 2022
Last Update
January 8 2026
Active Locations (4)
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1
Entebbe
Entebbe, Uganda
2
Iganga District Hospital
Iganga, Uganda
3
Jinja Regional Referral Hospital
Jinja, Uganda
4
Masaka Regional Referral Hospital
Masaka, Uganda