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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04945967
Eligibility Criteria:
Inclusion Criteria:
1. Premature infants born 28 to 34 weeks of gestational age
2. Has achieved oral feeding readiness in the form of :
* Stable cardiorespiratory status
* Fully feed through orogastric tube of 120ml/kg/day without vomiting or bloating
* Strong and rhythmic non-nutritive sucking (NNS), measured objectively using sucking mechanism evaluation system (5 to 10 non-nutritive sucks per burst, the repetitive pattern was stable, with a pause of 4 to 9 seconds, and the amplitude was -16.7 to -87 mmHg)
3. Parent/guardian give consent to participate
Exclusion Criteria:
1. Craniomaxillofacial malformation
2. Neonatal asphyxia with 5-minute APGAR score is less than 7
3. Grade 3 and 4 intraventricular hemorrhage
4. Using endotracheal tube at the time of assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
34 Weeks
Study:
NCT04945967
Study Brief:
Protocol Section:
NCT04945967