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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02661360
Eligibility Criteria:
Inclusion Criteria:
* all infants born before 34 weeks gestational age will be included as long as they do not have any exclusion criteria
* infants born before 34 weeks gestational age is 33 weeks 3 days to 35 weeks 0 days, with attainment of exclusive bottle feeding at 36 weeks gestational age at the earliest.
* Infants who are multiples will be included but restricted to twins and triplets.
* Infants will only be included if their parents provide informed consent for participation of their infant in the study.
Exclusion Criteria:
The exclusion criteria are factors commonly associated with feeding problems in infants beyond prematurity, including:
* Infants who are exclusively breastfed
* Higher order multiples than twins and triplets (ie. quadruplets)
* Infants with conditions that may affect feeding performance:
1. Grades III and IV intraventricular hemorrhage
2. Necrotizing enterocolitis
3. Congenital cardiac anomalies (except medically managed patent ductus arteriosus)
4. Genetic syndromes
5. Craniofacial abnormalities
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Study:
NCT02661360
Study Brief:
Protocol Section:
NCT02661360