PIOMI plus time‑based feeding to help preterm babies start oral feeds and gain weight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled experiment that assigns eligible preterm infants to one of three groups: PIOMI (Premature Infant Oral Motor Intervention), a chronobiological nutrition/feeding schedule, or usual care. The team will track feeding readiness, time to full transition to oral feeding, and weight gain while monitoring clinical stability. Eligible infants are 29–33 weeks postnatal age with stable vital signs and APGAR scores ≥4, and common neonatal complications or mechanical ventilation are exclusion criteria. Interventions combine structured oral‑motor stimulation and timing of feeds to align with biological cues, with outcomes compared across groups.

Why it matters

Who can join: the full rules

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,

Where it's running

• Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing
  Aydin, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Esra Bozkurt, MSc
• Email: e.cifci06@gmail.com
• Phone: +905468213722

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.