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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01683565
First received: September 4, 2012
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Child Behavior - ASD [ Time Frame: Pre-baseline to 90 days post randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (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
Genders Eligible for Study:   Both
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 as the primary language at home; 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
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
Investigators
Principal Investigator: Sarah Keim Nationwide Children's Hospital
  More Information

No publications provided

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: April 26, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013