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Simple mouth exercises may help preterm babies feed sooner
NCT ID NCT07306793
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a 5-minute daily mouth exercise routine (PIOMI) combined with feeding at specific times of day helps preterm infants (29-33 weeks old) transition to full oral feeding and gain weight. 54 babies will be monitored for 14 days. The goal is to improve feeding readiness and body weight without medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral motor intervention (PIOMI) and chronobiological feeding schedule
- What this could lead to
- If successful, this could lead to a simple, drug-free way to help preterm babies learn to feed by mouth sooner and gain weight faster.
- What could go wrong
- This is a small, early-stage study with only 54 infants, so results may not apply to all preterm babies. The intervention is behavioral, so benefits may be modest.
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 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Sep 2026
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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29 to 33 weeks
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Preterm infants with a postnatal age of 29-33 weeks, * Whose vital signs and clinical condition have been stable for at least 24 hours, * Whose APGAR score at 1 and 5 minutes (Activity-Pulse-Grimace-Appearance-Respiration) is 4 or higher. Exclusion Criteria: * Infants with major congenital anomalies (such as congenital heart disease, cleft palate, cleft lip) or birth trauma, * Infants with RDS, * Infants diagnosed with asphyxia, * Infants with intraventricular hemorrhage, * Infants with Neonatal Withdrawal Syndrome, * Infants with Fetal Alcohol Syndrome, * Infants included in the study group who develop any complications or whose stable condition deteriorates during the follow-up period, * Infants with feeding intolerance or who are interrupted from feeding for more than 48 hours, * Infants who develop sepsis, * Infants who develop necrotizing enterocolitis, * Infants receiving mechanical ventilation support, * Infants who receive narcotic analgesia or sedation,
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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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Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing
RECRUITINGAydin, Turkey (Türkiye)
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