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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT06765720
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants with a gestational age of ≥30 weeks at birth, determined according to the mother's last menstrual period, and appropriate for gestational age,
* Postmenstrual age of ≥30 weeks at the time of inclusion in the study,
* Recommended for enteral feeding by a neonatologist,
* Infants starting enteral feeding for the first time and fed at three-hour intervals using gravity-assisted nasogastric or orogastric tubes,
* Infants who have not undergone oral feeding trials,
* Infants who have not received any oral motor interventions,
* Infants whose parents have given consent for inclusion in the study and signed an informed consent form after being provided with detailed information.
Exclusion Criteria:
* Infants receiving mechanical ventilation support during the study,
* Infants with an umbilical catheter,
* Infants who received intubation, CPAP, or nasal prong oxygen support for more than 14 days before inclusion in the study,
* Infants with craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis,
* Infants with any gastrointestinal, neurological, or chromosomal disease (e.g., necrotizing enterocolitis, grade III and IV intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, Down syndrome, and other diseases),
* Infants with severe bronchopulmonary dysplasia according to the criteria of Jobe and Bancalari (2001) or requiring surgical treatment for patent ductus arteriosus.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Weeks
Maximum Age:
36 Weeks
Study:
NCT06765720
Study Brief:
Protocol Section:
NCT06765720