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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT03797157
Eligibility Criteria:
Inclusion Criteria:
* Gestational age at birth 22+0-27+6: based on prenatal ultrasonography.
* Enteral feeds \< 100 mL/kg/day at the day of randomisation.
* Written informed consent from the legal guardians of the infant.
* The home clinic of the infant has the logistics of maintaining the intervention until gestational week 34+0
Exclusion Criteria:
* Lethal or complicated malformation known at the time of inclusion
* Chromosomal anomalies known at the time of inclusion
* No realistic hope for survival at the time of inclusion
* Gastrointestinal malformation known at the time of inclusion
* Abdominal surgery before the time of inclusion
* Participation in another intervention trial aiming at having an effect on growth, nutrition, feeding intolerance or severe complications such as NEC and sepsis
* Infants having nutrient fortifier or formula prior to randomisation
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03797157
Study Brief:
Protocol Section:
NCT03797157