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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-01-31

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.

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Detailed Description

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Conditions

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Preterm Birth Child Development Child Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LCPUFA Oil Supplement

EPA + DHA + GLA + OA oil supplement

Group Type EXPERIMENTAL

LCPUFA oil supplement

Intervention Type DRUG

2.5mL per day for 90 days

Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)

Canola Oil Placebo

Group Type PLACEBO_COMPARATOR

Canola Oil Placebo

Intervention Type OTHER

2.5mL per day for 90 days

Interventions

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LCPUFA oil supplement

2.5mL per day for 90 days

Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)

Intervention Type DRUG

Canola Oil Placebo

2.5mL per day for 90 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Child born at less than or equal to 29 completed weeks' gestation;
2. Child between 18 months, 0 days and 38 months, 30 days old chronological age;
3. Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.
4. Child showing some autistic symptoms;
5. Child between the 5th and 95th percentiles (per WHO growth chart) for weight at his/her most recent hospital visit;
6. English spoken in the home, demonstrate ability to communicate in English well-enough to understand study, informed consent, and study questionnaires; and
7. Have informed consent on file.

Exclusion Criteria

1. Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x per week;
2. Unable to tolerate venipuncture;
3. Any major malformation that would preclude participation;
4. Cerebral Palsy (quadriparesis only);
5. Deafness;
6. Blindness;
7. Bleeding disorder;
8. Type I diabetes;
9. Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis;
10. Non febrile seizure in the last month without a clear and resolved etiology;
11. Feeding problem that may inhibit full participation;
12. Known fish allergy;
13. Known canola/rapeseed allergy or sensitivity; or
14. Recorded score of \<70 on Bayley Cognitive Section within the past year.

Minimum Eligible Age

18 Months

Maximum Eligible Age

39 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No