CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
LCPUFA oil supplement +1 moredrug
Likely dose
LCPUFA oil supplement 2.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01683565
NCT01683565Phase 4Completed
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Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

Sarah Keim·interventional·Posted Sep 12, 2012·Updated Jan 3, 2019

In Brief

A Phase 4 clinical trial evaluating LCPUFA oil supplement and Canola Oil Placebo for Preterm Birth and 2 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth, Child Development, Child Behavior
CountriesUnited States
CollaboratorsCures Within Reach, Marci and Bill Ingram Fund for Autism Spectrum Disorders Research

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 12, 2012
Enrollment StartSep 1, 2012
Primary CompletionMar 1, 2015
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.8 years ago

Interventions

LCPUFA oil supplementdrug

2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)

Canola Oil Placeboother

2.5mL per day for 90 days