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Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

NCT01683565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-01-03

Study results available
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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.

Conditions

Interventions

DRUG

LCPUFA oil supplement

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

OTHER

Canola Oil Placebo

2.5mL per day for 90 days

Sponsors & Collaborators

  • Cures Within Reach

    collaborator OTHER

  • Marci and Bill Ingram Fund for Autism Spectrum Disorders Research

    collaborator UNKNOWN

  • Sarah Keim

    lead OTHER

Principal Investigators

  • Sarah Keim, PhD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
39 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-03-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01683565 on ClinicalTrials.gov