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Plastic bag beats blanket for preemie warmth?

NCT ID NCT07661511

Disease control Sponsor: Mario Adrián Tienda Vázquez 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether wrapping premature babies in a plastic bag (polyethylene bag) keeps them warmer than the usual prewarmed blanket during transfer from the delivery room to the NICU. Sixty-seven babies weighing 2 kilograms or less were randomly assigned to one of the two methods. Researchers measured body temperature, heart rate, oxygen levels, and blood sugar to see which method better prevents hypothermia.

What this could mean

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

Active substance
Neonatal polyethylene bag (Neohelp®) and prewarmed blanket
What this could lead to
If the plastic bag works better, it could become a simple, low-cost way to prevent dangerous heat loss in premature babies during transfer.
What could go wrong
This is a small pilot study with only 67 babies, so results may not apply to all hospitals or situations. The plastic bag might not be as effective or safe in larger, more diverse groups.

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

67 people

The number who actually took part.

Started

Nov 2025

Finished

Feb 2026

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

0 days to 1 day

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: * Premature neonates born before 37 weeks of gestation * Birth weight ≤2000 grams * Born in the obstetric-surgical unit of the participating public hospital and requiring immediate intrahospital transfer to the Neonatal Intensive Care Unit (NICU) * Written informed consent provided by parents or legal guardians Exclusion Criteria: * Major congenital malformations * Need for immediate resuscitation procedures incompatible with application of the assigned intervention * Parents or legal guardians unable or unwilling to provide informed consent

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Hypothermia neonatal Neonatal Premature birth

Contacts and locations

Locations

  • Hospital de Especialidades del Niño y la Mujer

    Querétaro, Mexico

More trials for these conditions

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