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

Primary Purpose

Preterm Birth, Child Development, Child Behavior

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LCPUFA oil supplement
Canola Oil Placebo
Sponsored by
Sarah Keim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth

Eligibility Criteria

18 Months - 39 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LCPUFA Oil Supplement

Canola Oil Placebo

Arm Description

EPA + DHA + GLA + OA oil supplement

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Fatty Acid
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.

Full Information

First Posted
September 4, 2012
Last Updated
December 11, 2018
Sponsor
Sarah Keim
Collaborators
Cures Within Reach, Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
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1. Study Identification

Unique Protocol Identification Number
NCT01683565
Brief Title
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Official Title
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Keim
Collaborators
Cures Within Reach, Marci and Bill Ingram Fund for Autism Spectrum Disorders Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Child Development, Child Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCPUFA Oil Supplement
Arm Type
Experimental
Arm Description
EPA + DHA + GLA + OA oil supplement
Arm Title
Canola Oil Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LCPUFA oil supplement
Intervention Description
2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)
Intervention Type
Other
Intervention Name(s)
Canola Oil Placebo
Intervention Description
2.5mL per day for 90 days
Primary Outcome Measure Information:
Title
Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2
Description
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.
Time Frame
Baseline to 90 days post randomization
Title
Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
Description
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.
Time Frame
Baseline to 90 days post randomization
Secondary Outcome Measure Information:
Title
Fatty Acid
Description
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.
Time Frame
Baseline to 90 days post randomization
Other Pre-specified Outcome Measures:
Title
Feasibility: Future Full-scale Multi-site Study
Description
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.
Time Frame
Pre-baseline to 90 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
39 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Keim, PhD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35644107
Citation
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.
Results Reference
derived
PubMed Identifier
29490101
Citation
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.
Results Reference
derived
PubMed Identifier
28941976
Citation
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. Erratum In: Early Hum Dev. 2018 Mar 2;:
Results Reference
derived

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

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