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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT01788761
Eligibility Criteria:
Inclusion Criteria:
* Birthweight between 500-999 grams
* Apgar score greater than or equal to 3 at 5 minutes
* Infant free from any known major congenital anomalies or chromosomal/genetic anomalies
* Infant without any known cyanotic or complex congenital heart disease
* Infant NPO or on trophic enteral feedings than have been started less than 24 hours previously
* Infant without prior history of necrotizing enterocolitis or gastrointestinal perforation
* Infant without previous exposure to probiotics
* Infant that will be ready to start trophic feedings within the first 14 days of life
* Infant less than or equal to 14 days of age
* Infant born to HIV negative mother
* Written informed consent obtained from mother
Exclusion Criteria:
* Infant born to HIV positive mother
* Infant with history of prior probiotic exposure
* Infant greater than 14 days of age
* Infant on enteral feedings for greater than 24 hours
* Infant with major congenital anomaly/chromosomal or genetic anomaly
* Infant with cyanotic/complex congenital heart disease
* Infant with previous gastrointestinal perforation/necrotizing enterocolitis
* 5 minute Apgar score \< 3
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
14 Days
Study:
NCT01788761
Study Brief:
Protocol Section:
NCT01788761