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Could a plastic bag save newborn lives? simple method tested to prevent hypothermia

NCT ID NCT01604317

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether placing premature or low-birth-weight babies in plastic bags right after birth helps keep them warm. About 182 infants born at 29-36 weeks will be wrapped in plastic bags during resuscitation and for one hour after birth. The goal is to see if this simple, low-cost method reduces the risk of hypothermia compared to standard care alone.

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 works, this simple, low-cost method could help prevent dangerous cold in newborns in resource-limited settings.
What could go wrong
This is a small, early-stage study (182 infants) testing a short-term intervention. Results may not apply to all newborns or settings, and there is a risk of overheating or skin irritation.

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.

Participants

182 people

The number who actually took part.

Started

Jun 2012

Expected to finish

Aug 2026

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

1 minute to 1 hour

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 29-36 6/7weeks or birth weight 1,400-2500g * Delivery in the hospital Exclusion Criteria: * Infant admitted to the NICU * Birth weight less than 1,400g * Abdominal wall defect or myelomeningocele * Major congenital anomalies * Blistering skin disorder

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Conditions

The condition(s) this trial relates to.

Hypothermia

As listed by the trial registrant

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

Hypothermia Immature newborn

Contacts and locations

Locations

  • University Teaching Hospital

    Lusaka, Zambia

More trials for these conditions

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