PIOMI plus time‑based feeding to help preterm babies start oral feeds and gain weight
The Effect of Oral Motor Intervention and Chronobiological Approach to Feeding Models Applied to Preterm Infants on Infants' Readiness to Feed, Transition to Total Oral Feeding, and Body Weight
We will test whether a specific oral‑motor routine (PIOMI) and a time‑based (chronobiological) feeding approach help preterm infants born at 29–33 weeks begin oral feeding sooner and gain weight better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 29 Weeks to 33 Weeks |
| Sex | All |
| Sponsor | Aydin Adnan Menderes University Academic / other |
| Locations | 1 site (Aydin) |
| Trial ID | NCT07306793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm infants aged 29–33 weeks postnatal who have been clinically stable for at least 24 hours and had APGAR scores of 4 or higher at 1 and 5 minutes.
Not a fit: Infants with major congenital anomalies, respiratory distress, asphyxia, intraventricular hemorrhage, sepsis, necrotizing enterocolitis, mechanical ventilation, ongoing sedation/narcotics, or other complications are unlikely to benefit from the interventions in this protocol.
Why it matters
Potential benefit: If successful, this approach could shorten the time to full oral feeding and improve weight gain in preterm infants, potentially reducing hospital length of stay.
How similar studies have performed: Prior studies of oral motor interventions, including PIOMI, have reported faster transition to oral feeding and improved weight gain with no major safety signals, while chronobiological feeding approaches are biologically plausible but less extensively tested in preterm NICU populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aydin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.