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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT00874068
Eligibility Criteria:
Inclusion Criteria:
1. Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
2. Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
3. The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
4. The infant is apparently healthy.
5. Parental/ legal guardian written inform consent
6. Apgar after 5 minutes \>7
7. Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
8. At enrollment: clinical stability and acceptable weight gain
Exclusion Criteria:
1. The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)
2. The infant suffer from neonatal morbidities:
* Bronchopulmonary dysplasia (BPD)
* Intraventricular Hemorrhage3-4 (IVH)
* Necrotizing Enterocolitis (NEC)
3. Laboratory or clinical sings of Osteopenia
4. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
5. The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
6. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
1 Month
Study:
NCT00874068
Study Brief:
Protocol Section:
NCT00874068