Phase 4
Completed N=31
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Preterm Birth · Child Development · Child Behavior
Source: ClinicalTrials.gov NCT01683565 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 — -1.0; -0.2 score on a scale — p=0.67
◆ Published Evidence
Established
58citations · ~7 / year
ω-3 and ω-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers.
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.
Linked Publications (3)
-
ω-3 and ω-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers.
-
Omega-3 and -6 fatty acid supplementation and sensory processing in toddlers with ASD symptomology born preterm: A randomized controlled trial.
-
Effects of Omega-3-6-9 fatty acid supplementation on behavior and sleep in preterm toddlers with autism symptomatology: Secondary analysis of a randomized clinical trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.