Back to resultsOmega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Primary Purpose
Preterm Birth, Child Development
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
- Age 10-16 completed months (age corrected for prematurity) at baseline
- Discontinued regular breastfeeding and formula feeding at the time of randomization
- Gestational age < 35 completed weeks at birth
- English is primary language in home
- Informed consent obtained and signed
- Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance
Exclusion Criteria:
- Feeding problems
- Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
- Weight < 5th or > 95th percentile for age, per WHO growth charts
- Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
- Plans to move out of the area within the next 6 months
- Known corn allergy
- Known soy allergy
- Known fish allergy
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Docosahexaenoic Acid + Arachidonic Acid
Placebo
Arm Description
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Corn oil supplement
Outcomes
Primary Outcome Measures
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
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
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.
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
Secondary Outcome Measures
(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).
(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
Full Information
NCT ID
NCT01576783
First Posted
April 10, 2012
Last Updated
June 9, 2021
Sponsor
Sarah Keim
Collaborators
Allen Foundation Inc., March of Dimes, Cures Within Reach, Health Resources and Services Administration (HRSA)
1. Study Identification
Unique Protocol Identification Number
NCT01576783
Brief Title
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Official Title
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 26, 2012 (Actual)
Primary Completion Date
April 6, 2017 (Actual)
Study Completion Date
April 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Keim
Collaborators
Allen Foundation Inc., March of Dimes, Cures Within Reach, Health Resources and Services Administration (HRSA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
377 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docosahexaenoic Acid + Arachidonic Acid
Arm Type
Experimental
Arm Description
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Corn oil supplement
Intervention Type
Drug
Intervention Name(s)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Intervention Description
200 mg DHA+ 200 mg AA per day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
400 mg corn oil per day for 6 months
Primary Outcome Measure Information:
Title
Erythrocyte Fatty Acid Levels
Description
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
Title
Erythrocyte Fatty Acid Levels (Additional Data)
Description
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
Title
Enrollment and Trial Completion
Description
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
Title
Adherence
Description
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
Secondary Outcome Measure Information:
Title
(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
Description
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).
Time Frame
Baseline to 180 days post-randomization
Title
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Description
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
Other Pre-specified Outcome Measures:
Title
Brief Infant Sleep Questionnaire (BISQ)
Description
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).
Time Frame
Baseline to 180 days post-randomization
Title
Body Composition
Description
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.
Time Frame
Baseline to 180 days post-randomization
Title
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Description
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.
Time Frame
180 days post-randomization
Title
Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II)
Description
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.
Time Frame
180 days post-randomization
Title
Other Long-term Outcomes: Sleep (BISQ)
Description
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).
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Other Long-term Outcomes: Sleep (CSHQ)
Description
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.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Long-term Efficacy in Improving Cognition
Description
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.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Description
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.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Long-term Efficacy in Improving Executive Functions (CBCL)
Description
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.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Other Long-term Outcomes: Pervasive Developmental Problems
Description
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.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Other Long-term Outcomes: Language
Description
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.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Other Long-term Outcomes: Number of Participants With Developmental Delay
Description
Long-term (26-32 months of age) outcomes. This will be evaluated using caregiver reports/diagnoses of developmental delay.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
Title
Other Long-term Outcomes: Number of Participants With Behavior Difficulties
Description
Long-term (26-32 months of age) outcomes. This will be evaluated using caregiver reports/diagnoses of behavioral difficulties.
Time Frame
Long-term effect (approximately 8 months) after intervention completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
16 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 10-16 completed months (age corrected for prematurity) at baseline
Discontinued regular breastfeeding and formula feeding at the time of randomization
Gestational age < 35 completed weeks at birth
English is primary language in home
Informed consent obtained and signed
Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance
Exclusion Criteria:
Feeding problems
Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
Weight < 5th or > 95th percentile for age, per WHO growth charts
Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
Plans to move out of the area within the next 6 months
Known corn allergy
Known soy allergy
Known fish allergy
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
33768637
Citation
Boone KM, Pattison K, Pelak G, Sheppard KW, Rausch J, Yeates KO, Nelin MA, Klebanoff MA, Turner AN, Rogers LK, Keim SA. Docosahexaenoic and arachidonic acid supplementation at 1 year has mixed effects on development and behaviour at age 2 for preterm children. Acta Paediatr. 2021 Jul;110(7):2082-2083. doi: 10.1111/apa.15858. Epub 2021 Apr 12. No abstract available.
Results Reference
derived
PubMed Identifier
31984781
Citation
Sullivan JA, Wiese AM, Boone KM, Rausch J, Keim SA. To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial. Clin Trials. 2020 Apr;17(2):223-230. doi: 10.1177/1740774519893307. Epub 2020 Jan 27.
Results Reference
derived
PubMed Identifier
31538590
Citation
Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial. J Clin Sleep Med. 2019 Sep 15;15(9):1197-1208. doi: 10.5664/jcsm.7902.
Results Reference
derived
PubMed Identifier
30579584
Citation
Boone KM, Nelin MA, Chisolm DJ, Keim SA. Gaps and Factors Related to Receipt of Care within a Medical Home for Toddlers Born Preterm. J Pediatr. 2019 Apr;207:161-168.e1. doi: 10.1016/j.jpeds.2018.10.065. Epub 2018 Dec 19. Erratum In: J Pediatr. 2019 Dec;215:289.
Results Reference
derived
PubMed Identifier
30357263
Citation
Keim SA, Boone KM, Klebanoff MA, Turner AN, Rausch J, Nelin MA, Rogers LK, Yeates KO, Nelin L, Sheppard KW. Effect of Docosahexaenoic Acid Supplementation vs Placebo on Developmental Outcomes of Toddlers Born Preterm: A Randomized Clinical Trial. JAMA Pediatr. 2018 Dec 1;172(12):1126-1134. doi: 10.1001/jamapediatrics.2018.3082. Erratum In: JAMA Pediatr. 2019 Dec 1;173(12):1215.
Results Reference
derived
Learn more about this trial
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
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