An interventional study of PIOMI study group and Nutrition Study Group with a Chronobiological Approach in Neonatal İntensive Care, Nutrition With A Chronobiological Approach and Readiness For Feding, sponsored by Aydin Adnan Menderes University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 29 Weeks to 33 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Supportive care
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.
Premature birth is defined as birth occurring before the 37th week of gestation, and approximately 15 million babies are born this way worldwide each year. Premature babies experience feeding difficulties because their oral feeding skills, sucking-swallowing-breathing coordination, and oral structures are not fully developed. Their oral motor systems typically mature between 32-34 weeks of gestation. The development of the oral motor system is crucial for adequate nutrition, growth, and weight gain. Several methods are used to improve the oral motor development of premature babies. Oral motor interventions involve physical stimuli applied to intraoral structures such as the lips, tongue, cheeks, gums, and palate. These methods aim to increase the functional strength of oral muscles and target neuro-behavioral synergy.
Oral motor interventions applied in NICUs have been shown to accelerate the transition to oral feeding, increase weight gain, and shorten hospital stays in premature infants. Premature Infant Oral Motor Intervention (PIOMI) is one of the interventions applied in NICUs. Studies have shown that PIOMI is more effective than other interventions in this field. Furthermore, no negative side effects of PIOMI have been reported.
Breast milk is an ideal source of nutrition for the growth and development of preterm infants. It provides essential nutrients for the baby's growth and development, as well as containing biological cues that help regulate circadian rhythms. For the fetus, which has become accustomed to the mother's circadian rhythms during intrauterine life, it supports this transition process by providing similar cues after birth. The composition of breast milk can vary depending on gestational age, lactation stage, and pumping time. Differences are particularly observed between day and night breast milk in terms of circadian rhythms. Daytime milk contains higher levels of substances such as immune system-related nucleotides, interleukins, and antioxidants, while nighttime milk is rich in sleep-regulating components such as melatonin and tryptophan. This difference is important for the transmission of the mother's biological rhythms to the baby, contributing to the regulation of the baby's sleep-wake cycle and improving its environmental adaptation.
The chronobiological feeding model suggests that expressed breast milk be given in periods of day and night, or more specifically, in six-hour cycles, in accordance with the daily cycle. This approach aims to support the development of the infant's circadian rhythm through expressed breast milk in situations where breastfeeding is not possible. A review of the literature revealed no studies that combined PIOMI with chronobiological feeding. Therefore, this research was planned to determine the effects of oral motor intervention (PIOMI) and chronobiological feeding on feeding readiness, transition to total oral feeding and body weight in preterm infants hospitalized in the NICU.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 54 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Aydin Adnan Menderes University is the lead sponsor of 241 studies on the registry; 51 are open to participants now.
Compared within Premature Birth, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Weight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Premature infant group undergoing Oral Motor Intervention.
Other: PIOMI study group
Group of infants fed using chronobiological approaches
Other: Nutrition Study Group with a Chronobiological Approach
Control group.
Other: Control 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.
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.
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.
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
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
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
Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Supporting information: 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.
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