WithdrawnNot Applicable

Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

Stopped: Staff not available to commence study.

0Started 2024-11-19

Plain-language summary

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (\<32.0° C) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

Who can participate

Age range

10 Minutes – 2 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: * Estimated gestational age ≥32 0/7 - 36 6/7 weeks * Delivery in the hospital Exclusion Criteria: * Abdominal wall defect or myelomeningocele * Major congenital anomalies * Blistering skin disorder * Clinically unstable mothers secondary to cardiovascular and pulmonary conditions * Infants requiring respiratory support beyond 10 minutes after birth * Infant requiring NICU admission * C/section * Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant

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

Moderate or severe hypothermia at 1 hour after birth (Phase 1A)

Timeframe: 1 hour after birth

Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)

Timeframe: 1 to 24 hours after birth

Trial details

NCT IDNCT03141736

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-12

View on ClinicalTrials.gov More Preterm Birth trials