Can a gentle touch soothe preterm babies on breathing machines?
NCT ID NCT07773896
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial investigates whether infant massage can improve comfort and physiological stability in late preterm infants receiving nCPAP, a form of non-invasive breathing support. Ninety infants will be divided into three groups: one receiving 5-minute massages twice daily, another receiving 10-minute massages twice daily, and a control group receiving standard care only. Researchers will measure comfort levels, heart rate, breathing rate, oxygen saturation, and body temperature before and after each session over three days. The goal is to see if massage, and at what duration, helps these fragile newborns feel better and stay stable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Infant massage
- What this could lead to
- If effective, massage could become a simple, drug-free way to improve comfort and physiological stability in preterm infants on breathing support.
- What could go wrong
- This is a small, early-stage study, and results may not apply to all preterm infants. Massage must be performed carefully to avoid disturbing the baby's stability.
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
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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
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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1 day to 1 month
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Newborns must: * Be between 34⁰/₇ and 36⁶/₇ weeks of gestation, * Be receiving nCPAP support, * Be hemodynamically stable, * Have started enteral feeding, * Have no congenital anomalies, * Their parents must voluntarily agree to participate in the study and provide written informed consent. Exclusion Criteria: * Newborns who: * Are receiving invasive mechanical ventilation, * Have undergone a surgical procedure, * Have a neurological disorder or a serious congenital anomaly, * Are receiving sedatives or neuromuscular blocking agents, * Whose clinical condition is not suitable for massage, * Who have a dermatological condition that could compromise skin integrity or a skin lesion that could interfere with massage, * Who have medical device-related pressure injuries caused by nCPAP.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tarsus University
Mersin, 33400, Turkey (Türkiye)
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