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Gentle wrapping may soothe sick Newborns' pain, study finds

NCT ID NCT07335263

Symptom relief Sponsor: Kutahya Health Sciences University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study looks at whether swaddling (wrapping snugly) or nesting (creating a cozy boundary) can lower pain and stress in newborns who need breathing support. About 100 babies born after 35 weeks will be watched for heart rate, oxygen levels, and stress signs. A painless saliva test will also check stress hormones. The goal is to find simple, drug-free ways to keep these fragile infants more comfortable.

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 100 people

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

Started

Feb 2025

Expected to finish

Dec 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

0 to 28 days

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: * Birth week greater than 35 weeks and birth weight greater than 2000 grams * Requirement for nasal CPAP/noninvasive mechanical ventilation * Legal guardians' consent to participate in the study * Postnatal diagnosis of transient tachypnea of the newborn Exclusion Criteria: Mother: * Taking cortisol-containing medication during the antenatal period * Taking narcotics during the antenatal period * Having chorioamnionitis * Having a metabolic disorder (adrenal insufficiency, etc.) Newborn: * Amniotic fluid stained with meconium * Being intubated * Having an Apgar score below 6 * Receiving analgesic or narcotic drugs for sedation * The newborn receiving cortisol-containing medication * Being unable to obtain a saliva sample or the sample being contaminated with blood * Signs of nasal injury during noninvasive mechanical ventilation * Congenital defects (spina bifida, gastroschisis, etc.) that prevent positioning using the swaddling or cradling methods * Resuscitation * Cerebral hypoxia-ischemia * Non-respiratory causes (congenital pneumonia, respiratory distress syndrome, congenital heart disease, hypocalcemia, persistent hypoglycemia, development of sepsis) * Hypocalcemia (low calcium level detected in blood gas sample taken while establishing an intravenous line prior to nCPAP)

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Conditions

The condition(s) this trial relates to.

perinatal disease

As listed by the trial registrant

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

Newborn Newborn diseases Non-pharmacological intervention Nonpharmalogical pain management Stress

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kütahya Health Sciences University

    RECRUITING

    Merkez, Kütahya, Turkey (Türkiye)

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