Phase 4
N=31
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Preterm Birth · Child Development · Child Behavior
Bottom Line
View on ClinicalTrials.gov: NCT01683565 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 — -1.0; -0.2 score on a scale — p=0.67
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- LCPUFA oil supplement (Drug); Canola Oil Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sarah Keim
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 |
-1.0; -0.2 | 0.67 |
| PRIMARY Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA) |
1.9; 0.9; 3.2; -3.2; -0.9; -0.8 | 0.22 |
| SECONDARY Fatty Acid |
2.15; -4.91; 2.56; -2.43; -3.07; -8.42 | 0.31 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01683565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.