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

Sponsor
Aydin Adnan Menderes University
Study ID
NCT07306793
Status
Recruiting
Apply to this trial

Conditions

  • Body Weight
  • Breast Milk
  • Neonatal İntensive Care
  • Nutrition
  • Nutrition With A Chronobiological Approach
  • Premature Birth
  • Readiness For Feding

Eligibility Criteria

Sex
ALL
Age
29 Weeks - 33 Weeks
Healthy Volunteers
Accepted

Interventions

  • PIOMI study group — OTHER
    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 — OTHER
    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 — OTHER
    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 Details

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.

Key Dates

First listed
Dec 29, 2025
Start date
Mar 1, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: PIOMI study group
    Premature infant group undergoing Oral Motor Intervention.
  • Experimental: Nutrition Study Group with a Chronobiological Approach
    Group of infants fed using chronobiological approaches
  • Other: No Intervention
    Control group.

Primary Outcome Measure

Readiness for Feeding [ Time Frame: Newborns At 29-33 Gestatıonal Weeks ]

Central Contacts

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