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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarah Keim
• Collaborators: Cures Within Reach; Marci and Bill Ingram Fund for Autism Spectrum Disorders Research

Criteria

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.