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

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

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

Conditions
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Preterm Birth, Child Development

Intervention / Treatment
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* Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 10-16 completed months (age corrected for prematurity) at baseline Discontinued regular breastfeeding and formula feeding at the time of randomization Gestational age < 35 completed weeks at birth English is primary language in home Informed consent obtained and signed 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: Feeding problems Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement. Weight < 5th or > 95th percentile for age, per WHO growth charts Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week Plans to move out of the area within the next 6 months Known corn allergy Known soy allergy Known fish allergy

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 16 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docosahexaenoic Acid + Arachidonic Acid<br>Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) | Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)<br>* 200 mg DHA+ 200 mg AA per day for 6 months<br>|
| Placebo Comparator: Placebo<br>Corn oil supplement | Dietary Supplement: Placebo<br>* 400 mg corn oil per day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythrocyte Fatty Acid Levels | This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc | Baseline to 180 days post-randomization | 
| Erythrocyte Fatty Acid Levels (Additional Data) | This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc | Baseline to 180 days post-randomization | 
| Enrollment and Trial Completion | The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc. | Baseline to 180 days post-randomization | 
| Adherence | The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc | Baseline to 180 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form) | Infant Behavior Questionnaire-Revised (IBQ-R; short form) was used to assess effortful control (12 items) and activity level (3 items). The IBQ-R measures early temperament-based inhibitory control,a key component of executive function as children mature. Scores range from 1 to 7, with higher scores indicating greater frequency of behaviors. IBQ-R scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the IBQ-R value at 180 days minus the IBQ-R value at baseline). | Baseline to 180 days post-randomization | 
| (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III) | Bayley Scales of Infant and Toddler Development, third edition, (Bayley-III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items,score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Bayley-III scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the Bayley-III value at 180 days minus the Bayley-III value at baseline). Secondary Outcome for 1st stage of project funded by Allen Foundation, Inc; Primary Outcome for 2nd stage of project funded by March of Dimes and Health Resources and Services Administration | Baseline to 180 days post-randomization |