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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT06631703
Eligibility Criteria:
Inclusion Criteria:
* The gestational week at the time of delivery is between 260-33+6 gestational weeks, determined according to the mother's last menstrual date and obstetric evaluation results.
* Started feeding with an orogastric catheter, in the process of transition from catheter feeding to oral feeding
* Meeting early feeding readiness criteria (stable respiration and oxygen saturation during feeding, responsiveness to perioral/oral stimulation and licking, etc.)
* 750 g or more during the study
* Stable vital signs (respiratory rate \<60/min, heart rate 140-185 beats/min, axillary temperature 36.5-37.4°C) (Acunaş et al., 2018)
* NICU admission ≤ 24 hours of life; protocol can be started within 72 hours,
* No muscle relaxants, sedatives, or severe neurological disease
* Allowing parents of premature infants
Exclusion Criteria:
* Congenital or chromosomal anomalies, lack of cardiorespiratory stabilization, birth asphyxia (cord ph/arterial ph \<7. 0), twin or more multiple births, intrauterine growth retardation, necrotizing enterocolitis, pneumothorax, skull fracture, severe atelectasis, circulatory disorder, severe sepsis, having a chest tube, having a history of pathologic jaundice, having a history of antenatal gastrointestinal system disease, born with cleft palate/lip, born to mothers with confirmed chorioamnionitis were excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
26 Weeks
Maximum Age:
33 Weeks
Study:
NCT06631703
Study Brief:
Protocol Section:
NCT06631703