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

December 11, 2018 updated by: Sarah Keim
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Child born at less than or equal to 29 completed weeks' gestation;
  2. Child between 18 months, 0 days and 38 months, 30 days old chronological age;
  3. Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.
  4. Child showing some autistic symptoms;
  5. Child between the 5th and 95th percentiles (per WHO growth chart) for weight at his/her most recent hospital visit;
  6. English spoken in the home, demonstrate ability to communicate in English well-enough to understand study, informed consent, and study questionnaires; and
  7. Have informed consent on file.

Exclusion Criteria:

  1. Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x per week;
  2. Unable to tolerate venipuncture;
  3. Any major malformation that would preclude participation;
  4. Cerebral Palsy (quadriparesis only);
  5. Deafness;
  6. Blindness;
  7. Bleeding disorder;
  8. Type I diabetes;
  9. Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis;
  10. Non febrile seizure in the last month without a clear and resolved etiology;
  11. Feeding problem that may inhibit full participation;
  12. Known fish allergy;
  13. Known canola/rapeseed allergy or sensitivity; or
  14. Recorded score of <70 on Bayley Cognitive Section within the past year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2
Time Frame: Baseline to 90 days post randomization
The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline.
Baseline to 90 days post randomization
Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
Time Frame: Baseline to 90 days post randomization
Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline.
Baseline to 90 days post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from the first study visit to the final study visit.
Baseline to 90 days post randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Future Full-scale Multi-site Study
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.
Pre-baseline to 90 days post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarah Keim

Collaborators

Cures Within Reach
Marci and Bill Ingram Fund for Autism Spectrum Disorders Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 752311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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