Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
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|ClinicalTrials.gov Identifier: NCT01683565|
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth Child Development Child Behavior||Drug: LCPUFA oil supplement Other: Canola Oil Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||January 2017|
Experimental: LCPUFA Oil Supplement
EPA + DHA + GLA + OA oil supplement
Drug: LCPUFA oil supplement
2.5mL per day for 90 days
Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)
|Placebo Comparator: Canola Oil Placebo||
Other: Canola Oil Placebo
2.5mL per day for 90 days
- Child Behavior - ASD [ Time Frame: Pre-baseline to 90 days post randomization ]One primary aim of this study are to examine treatment effects demonstrating change in ASD behaviors as measured by the PDDST-II Stage 2, BITSEA, response to joint attention, and response to name from pre-baseline to 90 days post randomization.
- Fatty Acid [ Time Frame: Baseline to 90 days post randomization ]The secondary outcome measures in this trial involve an examination of change in fatty acids and OS response from the first study visit (Time 1) to the third/final study visit (Time 3).
- Feasibility [ Time Frame: Pre-baseline to 90 days post randomization ]Feasibility of a future full-scale multi-site study is assessed by examining the number of children screened, the proportion of these children who screen positive for ASD, the number of children who agree to participate in the trial, the number of children who return for the second and third study visits, baseline differences in individual fatty acids between the intervention and comparison groups, and adherence to the assigned treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683565
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Sarah Keim, PhD||Nationwide Children's Hospital|