Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa (NCT02811432) | Clinical Trial Compass
CompletedNot Applicable
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
Uganda2,221 participantsStarted 2019-10-13
Plain-language 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.
Who can participate
Age range
1 Hour – 48 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality Within 7 Days
Timeframe: 7 days
Trial details
NCT IDNCT02811432
SponsorLondon School of Hygiene and Tropical Medicine