TerminatedNot Applicable

Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

Stopped: In response to COVID pandemic

The Gambia279 participantsStarted 2018-05-20

Plain-language 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.

Who can participate

Age range

1 Hour – 24 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: * 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 Exclusion Criteria: * 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

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

All-cause Mortality

Timeframe: 28 days

Trial details

NCT IDNCT03555981

SponsorLondon School of Hygiene and Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-20

Results submitted2021-09-22

View on ClinicalTrials.gov More Preterm Infant trials