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 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT06315127
Eligibility Criteria:
Inclusion Criteria:
Infants admitted to the well-baby unit at Sinai Health whose parent(s) intend to feed parent milk and who require supplementation:
* Infants of gestational/ type 1/ type 2 diabetic mothers
* Infants who are born small for gestational age (SGA) by using a sex-specific reference population and determining if their birth weight falls below the 10th percentile for gestational age
* Infants with a birth weight less than 2.5 kg
* Late preterm infants born between 35 0/7-36 6/7 weeks of gestational age
Exclusion Criteria:
* Enrollment in any other clinical study affecting nutritional management during the feeding intervention; anticipated change in primary caregiver (person providing the feed) prior to 4 months; refusal to consent to donor milk; supplementation with formula prior to enrollment; any physical condition that may impact growth (ex: skeletal dysplasia).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
2 Hours
Study:
NCT06315127
Study Brief:
Protocol Section:
NCT06315127