This trial is active, not recruiting.

Conditions preterm birth, child development, child behavior
Treatments lcpufa oil supplement, canola oil placebo
Phase phase 4
Sponsor Sarah Keim
Start date September 2012
End date July 2017
Trial size 31 participants
Trial identifier NCT01683565, 752311


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
EPA + DHA + GLA + OA oil supplement
lcpufa oil supplement
2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)
(Placebo Comparator)
canola oil placebo
2.5mL per day for 90 days

Primary Outcomes

Child Behavior - ASD
time frame: Pre-baseline to 90 days post randomization

Secondary Outcomes

Fatty Acid
time frame: Baseline to 90 days post randomization

Eligibility Criteria

Male or female participants from 18 months up to 39 months old.

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, Angleman 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.

Additional Information

Official title Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Principal investigator Sarah Keim
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Nationwide Children's Hospital.