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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01683565
First received: September 4, 2012
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.

Condition Intervention Phase
Preterm Birth Child Development Child Behavior Drug: LCPUFA oil supplement Other: Canola Oil Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

Further study details as provided by Sarah Keim, Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.


Enrollment: 31
Actual Study Start Date: September 2012
Study Completion Date: January 2017
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Months to 39 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683565

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Sarah Keim
Cures Within Reach
The Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
Investigators
Principal Investigator: Sarah Keim, PhD Nationwide Children's Hospital
  More Information

Responsible Party: Sarah Keim, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01683565     History of Changes
Other Study ID Numbers: 752311
Study First Received: September 4, 2012
Last Updated: June 29, 2017

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 18, 2017