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Plastic bag trick to warm preterm babies never tested

NCT ID NCT03141736

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to see if placing preterm babies in a plastic bag during kangaroo mother care (skin-to-skin contact) could prevent hypothermia. It aimed to enroll infants born at 32 to 36 weeks. However, the trial was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plastic bag
What this could lead to
If it had worked, this could have pointed toward a low-cost way to prevent dangerous cold in preterm babies.
What could go wrong
The trial was withdrawn before it started, so no results exist. Even if run, the approach might not work or could cause overheating.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Nov 2024

An estimate. Start dates often move.

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 minutes to 2 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hypothermia Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothermia, newborn Preterm birth

More trials for these conditions

Other studies related to the condition(s) this trial covers.