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

Completed · Phase 4 · Has a placebo group

Conditions studied: Preterm Birth, Child Development, Child Behavior

In brief

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

Key facts

Study ID

NCT01683565

Run by

Sarah Keim

People needed

31

Starts

2012-09-01

Expected to finish

2017-01-01

Last updated by the study team

2019-01-03

Who can join

Age: 2 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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