Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
This trial is active, not recruiting.
|Conditions||preterm birth, child development, child behavior|
|Treatments||lcpufa oil supplement, canola oil placebo|
|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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
EPA + DHA + GLA + OA oil supplement
Child Behavior - ASD
time frame: Pre-baseline to 90 days post randomization
time frame: Baseline to 90 days post randomization
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.
|Official title||Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood|
|Principal investigator||Sarah Keim|
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