CompletedNot Applicable

Neonatal Warming to Prevent Hypothermia

United States52 participantsStarted 2020-12-01

Plain-language summary

Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of c-section in babies born between 32 and 36 weeks to determine if it reduces the risk of hypothermia.

Who can participate

Age range

55 Years

Sex

FEMALE

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: * Patients who have non-emergent cesarean deliveries (defined as at least 2 hours prior to planned cesarean) * Gestational age between 32 weeks and 0 days and 36 weeks and 6 days determined per usual clinical parameters Exclusion Criteria: * Fetal anomalies or death * Maternal diabetes * Neonates with blistering skin conditions * Reversed end diastolic umbilical artery flow * Placental abruption * Chorioamnionitis * Monochorionic multifetal pregnancies * Inability to provide consent * Provider perception that patient is in significant pain and provider perceived contraindications to delayed cord clamping.

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

Temperature at Arrival to Warmer

Timeframe: 3 minutes

Trial details

NCT IDNCT04827394

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-21

Results submitted2024-03-05

View on ClinicalTrials.gov More Hypothermia trials