Ireland
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Recruiting Not applicable

The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight

NCT07306793 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-03-01
Last updated
2026-01-06

Condition(s) studied

Neonatal İntensive CareNutrition With A Chronobiological ApproachReadiness For FedingBody WeightBreast MilkNutritionPremature Birth

Investigational drug(s) / intervention(s)

PIOMI study groupNutrition Study Group with a Chronobiological ApproachControl group

PIOMI study group: Infants will be weighed at 8:30 AM wearing only a clean diaper, and the scale will be disinfected before and after each use. Preterm infants in this group will receive PIOMI treatment at their bedside for 5 minutes, once a day, 15 minutes before feeding times at 9:00 AM or 12:00 PM, for 14 days. Before starting the PIOMI treatment, the researcher will remove any jewelry and wash their hands hygienically. Following the PIOMI treatments, infants will be fed using the feeding method applied in the clinic, and this will be recorded. Infants will be monitored throughout their stay in the NICU.

Nutrition Study Group with a Chronobiological Approach: Newborns will be weighed at 8:30 a.m. wearing only a clean diaper, and the scale will be disinfected before and after each use. The researcher will provide training to the baby's mother on breast milk expression and storage. Breast milk storage bags and adhesive labels labeled "NIGHT MILK" and "DAY MILK" will be provided by the researcher. Mothers will be asked to express milk between 06:00 and 17:59, place it in a breast milk storage bag, attach the "DAY MILK" label, and write their name, surname, date, and time on it. For milk expressed between 18:00 and 05:59, they will place it in a breast milk storage bag, attach the "NIGHT MILK" label, and write their name, surname, date, and time on it, and bring their milk to the unit in this manner. Newborns in this group will be fed using breast milk that is chronobiologically matched.

Control group: Newborns will be weighed at 8:30 AM wearing only a clean diaper, and the scale will be disinfected before and after each use. No procedures will be performed on these infants outside of the clinical routine. Infants will be fed using the same feeding method as in the clinic. Infants will be monitored throughout their stay in the NICU.

Study summary

This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding and body weight.

Eligibility

Sex
ALL
Min age
29 Weeks
Max age
33 Weeks
Healthy volunteers
Accepted
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,

Primary outcome measure(s)

  • Readiness for Feeding — Newborns At 29-33 Gestatıonal Weeks
    On days 1, 8, 11, and 14 of the study, the readiness of the infants for oral feeding will be assessed using the Premature Infant Readiness for Oral Feeding Assessment Scale. The Turkish validity and reliability of this scale, developed by Çamur and Çetinkaya, shows a cutoff point of 29. The maximum possible score on the scale is 36. A higher score indicates better readiness.
  • Transitioning to Total Oral Feeding — Newborns at 29-33 Gestatıonal Weeks
    Infants' nutritional information will be assessed daily using an infant monitoring form.
  • Body Weight — Newborns at 29-33 Gestatıonal Weeks
    Infants' body weights will be measured on days 1, 8, 11, and 14, on the day they start total oral feeding, and on the day they are discharged, at 8:30 AM, wearing only a clean diaper.

Trial sites (1)

FacilityCityRegionStatus
Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing Aydin Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07306793 on ClinicalTrials.gov ↗ ← All trials in Turkey