The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
377
200 mg DHA+ 200 mg AA per day for 6 months
400 mg corn oil per day for 6 months
Nationwide Children's Hospital
Columbus, Ohio, United States
Erythrocyte Fatty Acid Levels
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Time frame: Baseline to 180 days post-randomization
Erythrocyte Fatty Acid Levels (Additional Data)
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Time frame: Baseline to 180 days post-randomization
Enrollment and Trial Completion
The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc.
Time frame: Baseline to 180 days post-randomization
Adherence
The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Time frame: Baseline to 180 days post-randomization
(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
Infant Behavior Questionnaire-Revised (IBQ-R; short form) was used to assess effortful control (12 items) and activity level (3 items). The IBQ-R measures early temperament-based inhibitory control,a key component of executive function as children mature. Scores range from 1 to 7, with higher scores indicating greater frequency of behaviors. IBQ-R scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the IBQ-R value at 180 days minus the IBQ-R value at baseline).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to 180 days post-randomization
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Bayley Scales of Infant and Toddler Development, third edition, (Bayley-III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items,score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Bayley-III scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the Bayley-III value at 180 days minus the Bayley-III value at baseline). Secondary Outcome for 1st stage of project funded by Allen Foundation, Inc; Primary Outcome for 2nd stage of project funded by March of Dimes and Health Resources and Services Administration
Time frame: Baseline to 180 days post-randomization