Preterm Infant Oral Motor Intervention (PIOMI)
Launched by SULEYMAN DEMIREL UNIVERSITY · Feb 6, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Preterm Infant Oral Motor Intervention (PIOMI) trial is studying how a special feeding program, combined with kangaroo care (holding the baby skin-to-skin), can help preterm babies who are born between 28 and 32 weeks. The researchers want to see if this approach can improve the babies' weight gain, help them learn to feed by mouth, and reduce the time it takes for them to be ready to go home from the hospital.
To participate in the trial, babies need to be born within the specified gestational age range and be stable enough to handle the feeding transition. They should have a good Apgar score (which indicates how well they are doing right after birth) and not be on a breathing machine. Unfortunately, babies with certain congenital conditions or serious health issues will not be included in this study. Parents who choose to participate will be informed about the process and must give their consent for their baby to join. This research aims to improve the care and outcomes for preterm infants, ultimately helping them thrive as they grow.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Gestational age at birth is 28-32 weeks, depending on the mother's last menstrual period,
- • 29-32. can be administered PIOMI per week and can tolerate the transition to oral feeding,
- • Able to tolerate the transition to oral feeding according to the cue-based feeding model,
- • Maintains physiological stabilization (heart rate, oxygen saturation, respiratory rate) during the procedure when oxygen support is provided with room air or nasal cannula or hood.
- • Apgar score of 4 or higher at the 5th minute after birth
- • Not receiving mechanical ventilator support or 48 hours after weaning from mechanical ventilator support
- • Babies with written and verbal permission from their parents will be included in the research.
- Exclusion Criteria:
- • Those with congenital anomalies (cleft lip, cleft palate, gastroschisis, omphalocele, short bowel syndrome and other anomalies) According to the criteria of Jobe and Bancalari (2001), patients with severe bronchopulmonary dysplasia and patent ductus arteriosus (PDA) requiring surgical treatment Babies with gastrointestinal, neurological and genetic diseases (necrotizing enterocolitis, level 3 and 4 intracranial hemorrhage, periventricular 25 leukomalacia, hydrocephalus, down syndrome) will not be included in the study.
About Suleyman Demirel University
Suleyman Demirel University is a prominent educational and research institution dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, the university collaborates with healthcare professionals and researchers to explore new therapeutic approaches and enhance patient care. Its clinical trial initiatives focus on a range of medical fields, aiming to contribute valuable insights to the scientific community and foster the development of effective treatment strategies. By prioritizing ethical standards and rigorous methodologies, Suleyman Demirel University plays a pivotal role in shaping the future of healthcare through evidence-based research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Isparta, , Turkey
Patients applied
Trial Officials
Şerife Tutar, Dr.
Principal Investigator
Suleyman Demirel University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported