Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT06259604
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
29 Weeks
Maximum Age:
32 Weeks
Study:
NCT06259604
Study Brief:
Protocol Section:
NCT06259604