Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
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|ClinicalTrials.gov Identifier: NCT01683565|
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth Child Development Child Behavior||Drug: LCPUFA oil supplement Other: Canola Oil Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
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
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Sarah Keim, PhD||Nationwide Children's Hospital|