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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02371460
Eligibility Criteria:
Inclusion Criteria:
1. Age more than or equal to 16 years
2. Pre-term delivery (230/7- 286/7 weeks gestation)
3. No contraindication to breastfeeding
4. Subject intends to provide own breast milk to infant
5. Randomization before or at 72 hours post delivery
Exclusion Criteria:
MOTHERS
1. Mother is taking \> 250 mg of daily DHA supplementation for last 3 months
2. Mother who is currently enrolled or has participated in another clinical trial in which she had received an investigational drug or intervention within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)
3. Inability to comprehend and comply with study requirements
4. Participation in this study in a previous pregnancy
INFANTS
1. Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy)
2. Infant (or one of the infants in case of multiple pregnancy) who is currently enrolled in another clinical trial (unless approved by the Trial Coordinating Centre)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT02371460
Study Brief:
Protocol Section:
NCT02371460