Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Brief Infant Sleep Questionnaire (BISQ) |
The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ 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 BISQ value at 180 days minus the BISQ value at baseline). |
Baseline to 180 days post-randomization |
|
| Other |
Body Composition |
Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds). These measurements were converted to z scores for corrected age based on Child Growth Standards from the World Health Organization. The z-score indicates the number of standard deviations away from the mean. A z score of 0 is equal to the mean of a reference population (children the same age and sex). Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population. |
Baseline to 180 days post-randomization |
|
| Other |
Brief Infant Toddler Social Emotional Assessment (BITSEA) |
BITSEA measures socioemotional development in toddlerhood. Scores were summed to provide competence (range: 0-22) and problem (range: 0-62) scores, respectively. The problem scale is further divided into subscales: externalizing (6 items; range: 0-12), internalizing (8 items; range: 0-16), and dysregulation (8 items; range: 0-16). Additionally, 14 items comprise a red flag scale (range: 0-28). Eight items from the competence and nine items from the problem subscales are indicative of behaviors often seen in children with ASD. Each of the 17 ASD items was dichotomized to illustrate the presence (1) (i.e., competence items absent, problem items present) or absence (0) (i.e., competence items present, problem items absent) of each ASD behavior. Items were then summed to derive an ASD score (range: 0-17). Higher competence scores represent better functioning, whereas higher problem (including the problem subscales), red flag, and ASD scores were indicative of poorer functioning. |
180 days post-randomization |
|
| Other |
Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II) |
The PDDST-II is a clinically derived, caregiver-completed screener to assist in differentiating an ASD diagnosis from other disorders in children with developmental concerns, including those born preterm. The PDDST-II comprised 14 yes/no items that indicate the presence (1) or absence (0) of developmental concerns. Items were summed (possible range: 0-14) and higher scores represented greater developmental concern. |
180 days post-randomization |
|
| Other |
Other Long-term Outcomes: Sleep (BISQ) |
Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Brief Infant Sleep Questionnaire (BISQ).The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at post-intervention follow-up (approximately 8 months after the trial ended). The scores were calculated as a change between two time points (the BISQ value at post-intervention follow-up minus the BISQ value at baseline). |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Other Long-term Outcomes: Sleep (CSHQ) |
Long-term (26-32 months of age) outcomes. This will be evaluated using the total score on a subset of 13 items from the Children's Sleep Habits Questionnaire (CSHQ). The range in total score is 13-39. A higher score is indicative of more sleep problems. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Long-term Efficacy in Improving Cognition |
Long-term (26-32 months of age) cognitive outcome. This will be evaluated based on standard scores from the cognitive section of the Developmental Profile - 3. The range in standard scores is 40-140 with higher scores represent better cognitive ability. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Long-term Efficacy in Improving Executive Functions (BRIEF-P) |
Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P). The BRIEF-P yields five clinical scales, each measuring a different aspect of executive function: inhibit, shift, emotional control, working memory, and plan/organize. The clinical scales merge to create four broad indices of executive function: inhibitory self-control, flexibility, emergent metacognition, and global executive composite. A t-score of 50 is equal to the population mean with scores below 50 indicating better executive function, and scores above 50 indicating worse executive function for each reported aspect. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Long-term Efficacy in Improving Executive Functions (CBCL) |
Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the Attention Deficit/Hyperactivity Problems DSM oriented subscale and the Attention syndrome subscale of the Child Behavior Checklist 1.5-5 (CBCL). A t-score of 50 is equal to the population mean with scores below 50 indicating less behavioral problems, and scores above 50 indicating more behavioral problems. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Other Long-term Outcomes: Pervasive Developmental Problems |
Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Pervasive Developmental Problems DSM oriented scale on the Child Behavior Checklist 1.5-5 (CBCL). A t-score of 50 is equal to the population mean with scores below 50 indicating less problems and scores above 50 indicating more problems. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Other Long-term Outcomes: Language |
Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Communicative Development Inventory (CDI). On this measure, caregivers selected the number of words from a list of 100 common words that their child used. Scores reflect the total number of words, from the list of 100, that the child used. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Other Long-term Outcomes: Number of Participants With Developmental Delay |
Long-term (26-32 months of age) outcomes. This will be evaluated using caregiver reports/diagnoses of developmental delay. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Other |
Other Long-term Outcomes: Number of Participants With Behavior Difficulties |
Long-term (26-32 months of age) outcomes. This will be evaluated using caregiver reports/diagnoses of behavioral difficulties. |
Long-term effect (approximately 8 months) after intervention completion |
|
| Primary |
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 |
Baseline to 180 days post-randomization |
|
| Primary |
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 |
Baseline to 180 days post-randomization |
|
| Primary |
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. |
Baseline to 180 days post-randomization |
|
| Primary |
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 |
Baseline to 180 days post-randomization |
|
| Secondary |
(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). |
Baseline to 180 days post-randomization |
|
| Secondary |
(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 |
Baseline to 180 days post-randomization |
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