Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

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 development and behavior of children born preterm.

Official Title
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Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

Conditions
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Preterm Birth, Child Development, Child Behavior

Intervention / Treatment
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* Drug: LCPUFA oil supplement
* Other: Canola Oil Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child born at less than or equal to 29 completed weeks' gestation; Child between 18 months, 0 days and 38 months, 30 days old chronological age; Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled. Child showing some autistic symptoms; Child between the 5th and 95th percentiles (per WHO growth chart) for weight at his/her most recent hospital visit; English spoken in the home, demonstrate ability to communicate in English well-enough to understand study, informed consent, and study questionnaires; and Have informed consent on file. Exclusion Criteria: Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x per week; Unable to tolerate venipuncture; Any major malformation that would preclude participation; Cerebral Palsy (quadriparesis only); Deafness; Blindness; Bleeding disorder; Type I diabetes; Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis; Non febrile seizure in the last month without a clear and resolved etiology; Feeding problem that may inhibit full participation; Known fish allergy; Known canola/rapeseed allergy or sensitivity; or Recorded score of <70 on Bayley Cognitive Section within the past year.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 39 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: LCPUFA Oil Supplement<br>EPA + DHA + GLA + OA oil supplement | Drug: LCPUFA oil supplement<br>* 2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)<br>|
| Placebo Comparator: Canola Oil Placebo<br> | Other: Canola Oil Placebo<br>* 2.5mL per day for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 | The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline. | Baseline to 90 days post randomization | 
| Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA) | Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline. | Baseline to 90 days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatty Acid | The secondary outcome measures in this trial involve an examination of change in fatty acids from the first study visit to the final study visit. | Baseline to 90 days post randomization |