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

Sarah Keim

Status and phase: Completed; Phase 4

Conditions: Child Development; Child Behavior; Preterm Birth

Treatments: Other: Canola Oil Placebo; Drug: LCPUFA oil supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01683565

752311

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18 to 39 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

31 participants in 2 patient groups, including a placebo group

LCPUFA Oil Supplement

Experimental group

Description:

EPA + DHA + GLA + OA oil supplement

Treatment:

Drug: LCPUFA oil supplement

Canola Oil Placebo

Placebo Comparator group

Treatment:

Other: Canola Oil Placebo