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

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.
 
ClinicalTrials.gov Identifier: NCT01683565
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
Cures Within Reach
Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Actual Study Start Date : September 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : January 2017
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683565


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Sarah Keim
Cures Within Reach
Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
Investigators
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Principal Investigator: Sarah Keim, PhD Nationwide Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sarah Keim, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01683565    
Other Study ID Numbers: 752311
First Posted: September 12, 2012    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications