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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00492102
Eligibility Criteria:
Inclusion Criteria:
* VLBW infants between 500 - 1500 gm birth-weight born at Good Samaritan Hospital, Cincinnati, tolerating oral feeds equal to or more than 75 ml/kg/day and older than 7 days
Exclusion Criteria:
* Infants diagnosed with congenital malformations.
* Infants with an acute life threatening illness.
* Grade III or IV intra-ventricular hemorrhage.
* Patent ductus arteriosus being treated with indomethacin.
* Oral feedings are contra-indicated.
* Parents refuse consent.
* Attending physician does not wish the infant to be enrolled in the study.
* Infants with known hepatitis or HIV.
* Infants enrolled in any study using an investigational drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Days
Study:
NCT00492102
Study Brief:
Protocol Section:
NCT00492102