Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2018 |
| Start Date: | April 26, 2012 |
| End Date: | December 31, 2018 |
The purpose of this study is to examine whether supplementation with certain polyunsaturated
fatty acids can help the cognitive development of children born preterm.
fatty acids can help the cognitive development of children born preterm.
Inclusion Criteria:
1. Age 10-16 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
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