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 range10 Minutes – 2 Hours

SexALL

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

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