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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04360967
Eligibility Criteria:
Inclusion Criteria:
1. Having obtained his/her parents' (or his/her legally accepted representative's LAR's\]) written informed consent and having evidence of a personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of pertinent aspects of the study.
2. For infants in formula fed groups only: infants who require formula feeding due to lactation failure after minimum 2 rounds of breastfeeding counselling.
3. Birth Weight \< 10th percentile at term using the 2013 INTERGROWTH-21st Growth Charts for girls and boys.
4. Full term birth (gestational age ≥ 37 weeks and ≤ 41 weeks + 6 days), with gestational age estimated using fetal anthropometry by ultrasonography in early 1st trimester of pregnancy or calculated using the first day of the last menstrual period + 40 weeks if fetal anthropometry data for term calculation is not available or was collected after the 1st trimester.
5. Age \<45 days at time of enrollment
6. For infants in the HM-fed AGA comparator group only: born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and \<25kg/m2
Exclusion Criteria:
1. mothers with Type-1 Diabetes
2. mothers who smoked \>10 cigarettes per day during pregnancy.
3. mothers who used Illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\>3 alcoholic beverages per week) during pregnancy
4. Suspected or documented systemic or congenital infections (e.g Human Immunodeficiency virus, cytomegalovirus)
5. Genetic or any other type of congenital malformations, metabolic, cardiovascular, gastrointestinal, pancreatic or hepatic diseases or medical conditions that could compromise growth and/or food intake.
6. Fit to be discharged from neonatal intensive care unit (NICU) in \> 5 consecutive days with the exception of infants in the NICU due to jaundice only.
7. Known or suspected intolerance/ allergy to milk protein or any ingredient in the study formulas
8. For infants in the HM-fed groups only: infants who are consuming fortified human milk or formula.
9. Participation in any other interventional clinical trial during the 14 days prior to enrollment.
10. Infants or infant's family who in the investigator's judgement cannot be expected to comply with the protocol or study procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
44 Days
Study:
NCT04360967
Study Brief:
Protocol Section:
NCT04360967