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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04424667
Eligibility Criteria:
Inclusion Criteria (all criteria are necessary) :
* Infants weighing 1000 grams or less at birth
* Infants born or transferred before the third day of life to the participating centers
* Start enteral feeding in the first week of life
* Receive any amount of donor milk in the first 28 days of life
* Informed consent signed by parents or legal guardians
Exclusion Criteria:
* Language barrier
* Infants with chromosomopathies
* Infants with major congenital malformations
* Infants with severe asphyxiation (cord pH or first arterial pH \<7)
* Infants included in another clinical trial that modifies nutritional management
* Infants who previously fed with formula
Post-randomization exclusion criteria:
\- Randomized infant who do not fulfill inclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
28 Days
Study:
NCT04424667
Study Brief:
Protocol Section:
NCT04424667