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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT05465694
Eligibility Criteria:
Inclusion Criteria:
* Infants who are premature born ( ≥ 27 0/7 weeks of gestation)
* Infants who are at the postconceptional age from 34 0/7- 37 6/7 weeks of gestation
* Normal enterally fed with human milk or formula
* Infants whose mothers consented to study participation
Exclusion Criteria:
* Infants who were born depressed or with birth trauma
* Infants who have previous surgery
* Infants who have an intraventricular hemorrhage
* Infants who show signs of respiratory distress
* Infants who have an infection
* Infants with significant genetic disorders
* Infants who were on sedatives, muscle relaxants, and antiepileptic
* Infants who were born to opioid-using mothers
* Infants whose parents were unable to provide written informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
90 Days
Study:
NCT05465694
Study Brief:
Protocol Section:
NCT05465694