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

Phase 4

Completed

Conditions: Child Development
Child Behavior
Preterm Birth

Interventions: Drug: LCPUFA oil supplement
Other: Canola Oil Placebo

Registration Number: NCT01683565

Lead Sponsor: Sarah Keim

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCPUFA Oil Supplement	LCPUFA oil supplement	EPA + DHA + GLA + OA oil supplement
Canola Oil Placebo	Canola Oil Placebo	-

Primary Outcome Measures

Name	Time	Method
Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2	Baseline to 90 days post randomization	The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline.
Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)	Baseline to 90 days post randomization	Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline.

Secondary Outcome Measures

Name	Time	Method
Fatty Acid	Baseline to 90 days post randomization	The secondary outcome measures in this trial involve an examination of change in fatty acids from the first study visit to the final study visit.