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Simple warmth bundle may help newborns breastfeed better

NCT ID NCT07453264

Symptom relief Sponsor: Istanbul University - Cerrahpasa Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a set of simple steps to keep newborns warm right after birth, like drying them, putting on a hat, and skin-to-skin contact. The goal is to see if this helps babies stay warm, breathe steadily, and start breastfeeding sooner. The trial will include 140 full-term babies born vaginally.

What this could mean

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

Active substance
thermoregulation bundle (warm linens, hat, skin-to-skin, blanket)
What this could lead to
If it works, this simple care bundle could help more newborns stay warm and breastfeed sooner after birth.
What could go wrong
This is a small, early-stage trial with 140 participants, so results may not apply to all births. The bundle is already standard in many places, so the added benefit may be small.

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

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

2 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: * The baby is born vaginally * It is a singleton pregnancy, * The baby is born at term (gestational age 38-42 weeks), * The baby's Apgar score is ≥ 7 at 1 minute, * The baby's birth weight is between 2500-4000 grams, * The baby is exclusively breastfed, * The baby has no problems preventing breastfeeding, * The mother has no problems preventing breastfeeding, * There are no maternal or fetal complications. Exclusion Criteria: * The baby being preterm/postterm, * Starting formula feeding, * The baby having special care needs (intensive care, etc.), * The baby having intrauterine growth restriction (IUGR), genetic disease, etc.

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As listed by the trial registrant

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

Neonatal adaptation Neonatal hypothermia Thermoregulation

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi

    RECRUITING

    Kocaeli, darıca, 41000, Turkey (Türkiye)

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