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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT01894659
Eligibility Criteria:
Inclusion Criteria:
* Potential subjects are premature infants ≤ 34 weeks gestation and ≤ 7 days of age postnatally
Exclusion Criteria:
1. requirement for surgery
2. intraventricular hemorrhage (IVH) ≥ grade 3
3. neonates on medications such as morphine, fentanyl, versed, muscle relaxants, phenobarbital, or dilantin,
4. renal injury (plasma creatinine \> 1 mg/dl,
5. severe cyanotic heart disease or severe respiratory distress,
6. known abdominal wall or intestinal anomaly or injury (NEC),
7. chromosomal anomaly and (8) facial anomaly
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
7 Days
Study:
NCT01894659
Study Brief:
Protocol Section:
NCT01894659