Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2015-03
- Completion
- 2017-01
Outcome
Mixed primary results
registry analysis (other test); Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement vs Canola Oil Placebo; p = 0.67; Mixed Models Analysis; note: Threshold for statistical significance (<0.05) NCT01683565 ↗
registry MEAN Long Chain Polyunsaturated Fatty Acids (LCPUFA) Supplement: Austism Spectrum Disorder: -1.5 (Standard Deviation 2.6) score on a scale NCT01683565 ↗
registry MEAN Canola Oil Placebo: Austism Spectrum Disorder: 0.8 (Standard Deviation 3.8) score on a scale NCT01683565 ↗
registry analysis (other test); Long Chain Polyunsaturated Fatty Acids (LCPUFA) Supplement vs Canola Oil Placebo; p = 0.03; Mixed Models Analysis NCT01683565 ↗
paper treatment exhibited a greater reduction in ASD symptoms per the Brief Infant Toddler Social Emotional Assessment ASD scale than did those assigned to placebo PMID 29490101 ↗
Publications
- Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. 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. Early Hum Dev. 2022 Jun;169:105588. doi: 10.1016/j.earlhumdev.2022.105588. Epub 2022 May 19.
- Keim SA, Gracious B, Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Sheppard KW, Husk J, Rhoda DA. omega-3 and omega-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers. J Nutr. 2018 Feb 1;148(2):227-235. doi: 10.1093/jn/nxx047.
- Boone KM, Gracious B, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Omega-3 and -6 fatty acid supplementation and sensory processing in toddlers with ASD symptomology born preterm: A randomized controlled trial. Early Hum Dev. 2017 Dec;115:64-70. doi: 10.1016/j.earlhumdev.2017.09.015. Epub 2017 Sep 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omega-3-6-9 Junior | Other / unclassified | 2.5 ml | — |
Indications
No indication recorded.