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

• 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: Sarah Keim
• 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

Tracking Information

• First Submitted Date: September 4, 2012
• First Posted Date: September 12, 2012
• Results First Submitted Date: July 25, 2018
• Results First Posted Date: January 3, 2019
• Last Update Posted Date: January 3, 2019
• Actual Study Start Date: September 2012
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 11, 2018)

• 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.
• 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.

Original Primary Outcome Measures (submitted: September 7, 2012)

• 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.

Current Secondary Outcome Measures (submitted: December 11, 2018)

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.

Original Secondary Outcome Measures (submitted: September 7, 2012)

• 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.

Current Other Pre-specified Outcome Measures (submitted: December 11, 2018)

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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Preterm Birth
• Child Development
• Child Behavior

Intervention

• 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

Study Arms

• 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

Publications *

• 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.
• 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.
• 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;:

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2016): 31
• Original Estimated Enrollment (submitted: September 7, 2012): 40
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Months to 39 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01683565
• Other Study ID Numbers: 752311
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sarah Keim, Nationwide Children's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Sarah Keim
• Original Study Sponsor: Same as current

Collaborators

• Cures Within Reach
• Marci and Bill Ingram Fund for Autism Spectrum Disorders Research

Investigators

• Principal Investigator: Sarah Keim, PhD; Nationwide Children's Hospital

• PRS Account: Nationwide Children's Hospital
• Verification Date: December 2018