Neonatal İntensive CarePIOMINCT07306793
The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight
A study testing PIOMI study group and Nutrition Study Group with a Chronobiological Approach in people with Neonatal İntensive Care and Nutrition With A Chronobiological Approach, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal İntensive Care, Nutrition With A Chronobiological Approach, Readiness For Feding
- What is being tested?
- PIOMI study group and Nutrition Study Group with a Chronobiological Approach
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing
Aydin
Esra Bozkurt, MSc, 05468213722, e.cifci06@gmail.com
Esra Bozkurt, MSc
About this study
Official title: The Effect of Oral Motor Intervention and Chronobiological Approach to Feeding Models Applied to Preterm Infants on Infants' Readiness to Feed, Transition to Total Oral Feeding, and Body Weight
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.
Read the detailed description
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.
- Conditions
- Neonatal İntensive Care, Nutrition With A Chronobiological Approach, Readiness For Feding, Body Weight, Breast Milk, Nutrition
- Being tested
- PIOMI study group, Nutrition Study Group with a Chronobiological Approach, Control group
- 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
- Medical subject headings
- Body Weight, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIOMI study groupOther
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 ApproachOther
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 groupOther
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 group | Role | What they receive |
|---|---|---|
| PIOMI study group | Experimental | Premature infant group undergoing Oral Motor Intervention. Receives: Other: PIOMI study group |
| Nutrition Study Group with a Chronobiological Approach | Experimental | Group of infants fed using chronobiological approaches Receives: Other: Nutrition Study Group with a Chronobiological Approach |
| No Intervention | Other | Control group. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Newborns At 29-33 Gestatıonal Weeks
Transitioning to Total Oral Feeding
Infants' nutritional information will be assessed daily using an infant monitoring form.
Measured: 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.
Measured: Newborns at 29-33 Gestatıonal Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal İntensive CareStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozkurt, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306793
- Sponsor's protocol ID
- Interventional trial
- Acronym
- PIOMI
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Motor Intervention and Chronobiological Approach to Feeding Models Applied to Preterm Infants on Infants' Readiness to Feed, Transition to Total Oral Feeding, and Body Weight
- ClinicalTrials.gov ID
- NCT07306793
- Acronym / sponsor ID
- PIOMI / Interventional trial
- Conditions
- Neonatal İntensive Care, Nutrition With A Chronobiological Approach, Readiness For Feding, Body Weight, Breast Milk, Nutrition
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PIOMI study group | Experimental | Other: PIOMI study groupPremature infant group undergoing Oral Motor Intervention. |
| Nutrition Study Group with a Chronobiological Approach | Experimental | Other: Nutrition Study Group with a Chronobiological ApproachGroup of infants fed using chronobiological approaches |
| No Intervention | Other | Other: Control groupControl group. |
Who may qualify
- Ages
- 29 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIOMI study groupInfants 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. | Other | PIOMI study group |
| Nutrition Study Group with a Chronobiological ApproachNewborns 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. | Other | Nutrition Study Group with a Chronobiological Approach |
| Control groupNewborns 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. | Other | No Intervention |
Primary outcome
Readiness for Feeding
Time frame: 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
Time frame: Newborns at 29-33 Gestatıonal Weeks
Infants' nutritional information will be assessed daily using an infant monitoring form.
Body Weight
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIOMI study group and Nutrition Study Group with a Chronobiological Approach in people with Neonatal İntensive Care and Nutrition With A Chronobiological Approach, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Bozkurt, MSc (+905468213722, e.cifci06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness for Feeding (time frame: Newborns At 29-33 Gestatıonal Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.