Clinical trial NCT01576783: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Birth
Child Development
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Allen Foundation Inc.
name: March of Dimes
name: Cures Within Reach
name: Health Resources and Services Administration (HRSA)
First posted: 2012-04-12
Enrollment: 377
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age 10-16 completed months (age corrected for prematurity) at baseline
2. Discontinued regular breastfeeding and formula feeding at the time of randomization
3. Gestational age \< 35 completed weeks at birth
4. English is primary language in home
5. Informed consent obtained and signed
6. 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:

1. Feeding problems
2. Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
3. Weight \< 5th or \> 95th percentile for age, per WHO growth charts
4. Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
5. Plans to move out of the area within the next 6 months
6. Known corn allergy
7. Known soy allergy
8. Known fish allergy

Primary outcomes:
measure: Erythrocyte Fatty Acid Levels
timeFrame: Baseline to 180 days post-randomization
measure: Erythrocyte Fatty Acid Levels (Additional Data)
timeFrame: Baseline to 180 days post-randomization
measure: Enrollment and Trial Completion
timeFrame: Baseline to 180 days post-randomization
measure: Adherence
timeFrame: Baseline to 180 days post-randomization
Secondary outcomes:
measure: (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
timeFrame: Baseline to 180 days post-randomization
measure: (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
timeFrame: Baseline to 180 days post-randomization
Other outcomes:
measure: Brief Infant Sleep Questionnaire (BISQ)
timeFrame: Baseline to 180 days post-randomization
measure: Body Composition
timeFrame: Baseline to 180 days post-randomization
measure: Brief Infant Toddler Social Emotional Assessment (BITSEA)
timeFrame: 180 days post-randomization
measure: Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II)
timeFrame: 180 days post-randomization
measure: Other Long-term Outcomes: Sleep (BISQ)
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Other Long-term Outcomes: Sleep (CSHQ)
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Long-term Efficacy in Improving Cognition
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Long-term Efficacy in Improving Executive Functions (BRIEF-P)
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Long-term Efficacy in Improving Executive Functions (CBCL)
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Other Long-term Outcomes: Pervasive Developmental Problems
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Other Long-term Outcomes: Language
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Other Long-term Outcomes: Number of Participants With Developmental Delay
timeFrame: Long-term effect (approximately 8 months) after intervention completion
measure: Other Long-term Outcomes: Number of Participants With Behavior Difficulties
timeFrame: Long-term effect (approximately 8 months) after intervention completion
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sarah Keim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.