Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

• Status: Completed
• Trial end date: 2017-04-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarah Keim
• Collaborators: Allen Foundation Inc.; Cures Within Reach; Health Resources and Services Administration (HRSA); March of Dimes

Criteria

Inclusion Criteria:

1. Age 10-16 completed months (age corrected for prematurity) at baseline

2. Discontinued regular breastfeeding and formula feeding at the time of randomization

3. Gestational age < 35 completed weeks at birth

4. English is primary language in home

5. Informed consent obtained and signed

6. Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance

Exclusion Criteria:

1. Feeding problems

2. Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.

3. Weight < 5th or > 95th percentile for age, per WHO growth charts

4. Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week

5. Plans to move out of the area within the next 6 months

6. Known corn allergy

7. Known soy allergy

8. Known fish allergy