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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-33
SponsorAydin Adnan Menderes University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • PIOMI study group

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: PIOMI study groupExperimental treatment 1 intervention
Group B: Nutrition Study Group with a Chronobiological ApproachExperimental treatment 1 intervention
Group C: No InterventionOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Newborns At 29-33 Gestatıonal Weeks
2

Transitioning to Total Oral Feeding

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

Time frame
Newborns at 29-33 Gestatıonal Weeks
3

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.

Time frame
Newborns at 29-33 Gestatıonal Weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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