NCT01683565

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 3, 2019

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

September 4, 2012

Results QC Date

July 25, 2018

Last Update Submit

December 11, 2018

Conditions

Preterm BirthChild DevelopmentChild Behavior

Outcome Measures

Primary Outcomes (2)

  • Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2

    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)

    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 Outcomes (1)

  • Fatty Acid

    Baseline to 90 days post randomization

Other Outcomes (1)

  • Feasibility: Future Full-scale Multi-site Study

    Pre-baseline to 90 days post randomization

Study Arms (2)

LCPUFA Oil Supplement

EXPERIMENTAL

EPA + DHA + GLA + OA oil supplement

Drug: LCPUFA oil supplement

Canola Oil Placebo

PLACEBO COMPARATOR
Other: Canola Oil Placebo

Interventions

LCPUFA oil supplementDRUG

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

LCPUFA Oil Supplement
Canola Oil PlaceboOTHER

2.5mL per day for 90 days

Canola Oil Placebo

Eligibility Criteria

Age18 Months - 39 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (3)

  • 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.

    PMID: 35644107DERIVED

  • 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.

    PMID: 29490101DERIVED

  • 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.

    PMID: 28941976DERIVED

MeSH Terms

Conditions

Premature BirthChild Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavior

Results Point of Contact

Title
Dr. Sarah Keim
Organization
Nationwide Children's Hospital
Sarah.Keim@nationwidechildrens.org
614-722-3177

Study Officials

  • Sarah Keim, PhD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 12, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

January 1, 2017

Last Updated

January 3, 2019

Results First Posted

January 3, 2019

Record last verified: 2018-12

Locations

US(1)