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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT04639518
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
2. Infants' birth weight ≤1500 g and AGA.
3. Infant's gestational age \< 37 weeks.
4. Infant is clinically stable and does not have deteriorating respiratory function after birth.
5. Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.
Exclusion Criteria:
1. Parent(s) not willing / not able to comply with the requirements of study protocol.
2. Infant is experiencing early onset sepsis.
3. Major congenital or chromosomal abnormality known to affect growth.
4. Liver failure.
5. Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).
6. Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk.
7. Infant's participation in another interventional clinical trial.
8. Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
10 Days
Study:
NCT04639518
Study Brief:
Protocol Section:
NCT04639518