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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683565
First Posted: September 12, 2012
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cures Within Reach
The Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital
September 4, 2012
September 12, 2012
July 2, 2017
September 2012
March 2015   (Final data collection date for primary outcome measure)
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.
  • 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.
  • Child Behavior - ADHD [ Time Frame: Baseline to 90 days post randomization ]
    A second primary outcome measure is Attention deficit/hyperactive behaviors as measured by the CBCL 1.5-5 and C-TRF from baseline to 90 days post randomization.
Complete list of historical versions of study NCT01683565 on ClinicalTrials.gov Archive Site
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).
  • Biomarkers - Fatty Acid [ Time Frame: Baseline to 90 days post randomization ]
    A secondary outcome measures in this pilot trial involves an examination of change in fatty acids from baseline to 90 days post randomization.
  • Biomarkers - OS [ Time Frame: Baseline to 90 days post randomization ]
    A secondary outcome measure in this pilot trial involves an examination of change in OS response from baseline to 90 days post randomization.
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.
Not Provided
 
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Preterm Birth
  • Child Development
  • Child Behavior
  • 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
  • Experimental: LCPUFA Oil Supplement
    EPA + DHA + GLA + OA oil supplement
    Intervention: Drug: LCPUFA oil supplement
  • Placebo Comparator: Canola Oil Placebo
    Intervention: Other: Canola Oil Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
January 2017
March 2015   (Final data collection date for primary outcome measure)

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, Angleman 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.
Sexes Eligible for Study: All
18 Months to 39 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01683565
752311
Yes
Not Provided
Not Provided
Sarah Keim, Nationwide Children's Hospital
Sarah Keim
  • Cures Within Reach
  • The Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
Principal Investigator: Sarah Keim, PhD Nationwide Children's Hospital
Nationwide Children's Hospital
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP