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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04246333
Eligibility Criteria:
Inclusion Criteria:
* Infants admitted to the Johns Hopkins All Children's NICU before 72 hours of life
* Infants with a birth weight \<1251g
Exclusion Criteria:
* First obtained pH \<7.0
* APGAR \<5 at 5 minutes (The Apgar score is a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. Appearance, Pulse, Grimace, Activity, Respiration (APGAR))
* Infants on hydrocortisone for hypotension prior to randomization
* Infants with intrauterine growth restriction (IUGR) defined by birth weight ≤10th percentile for gestational age
* Infants with congenital anomalies, including but not limited to: Chromosomal abnormalities;Structural airway or pulmonary abnormalities (e.g. tracheoesophageal fistulas, cleft palate, congenital pulmonary adenomatous malformation, etc.); Abdominal anomalies requiring surgical interventions (e.g. intestinal atresia, intestinal webs, gastroschisis, omphalocele, anal atresia); Major cardiac anomalies
* Infants with a history of intestinal perforation or NEC
* Presence of gastrostomy tube
* Infants who have not been initiated on any volume of enteral feeds by 10 days of life
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
12 Months
Study:
NCT04246333
Study Brief:
Protocol Section:
NCT04246333