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

NCT07306793 | Recruiting

• 1 other identifier: Interventional trial
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Neonatal İntensive Care; Nutrition With A Chronobiological Approach; Readiness For Feding; Body Weight; Transitioning To Total Oral Feeding; Premature Infant Oral Motor Intervention (PIOMI); Prematüre

Outcome Measures

Primary Outcomes (3)

• Readiness for Feeding

  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.

  Newborns At 29-33 Gestatıonal Weeks

• Transitioning to Total Oral Feeding

  Infants' nutritional information will be assessed daily using an infant monitoring form.

  Newborns at 29-33 Gestatıonal Weeks

• Body Weight

  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.

  Newborns at 29-33 Gestatıonal Weeks

Study Arms (3)

PIOMI study group

EXPERIMENTAL

Premature infant group undergoing Oral Motor Intervention.

Other: PIOMI study group

Nutrition Study Group with a Chronobiological Approach

EXPERIMENTAL

Group of infants fed using chronobiological approaches

Other: Nutrition Study Group with a Chronobiological Approach

No Intervention

OTHER

Control group.

Other: Control group

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.

PIOMI study group

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.

Nutrition Study Group with a Chronobiological Approach

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.

No Intervention

Eligibility Criteria

• Age: 29 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing

Aydin, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Body Weight; Premature Birth

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Esra Bozkurt, MSc

CONTACT

+905468213722; e.cifci06@gmail.com

Seher Sarıkaya Karabudak, Associate Professor

CONTACT

+905054483703; ssarikaya@adu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: This is a randomized controlled experimental study. There are three groups: the PIOMI study group, the chronobiological feeding model study group, and a control group.

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)