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Preterm BirthNCT05191823

Omega Tots Long Term Follow-up

A study testing Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) in people with Preterm Birth and Child Development, run by Sarah Keim at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old. Read more about this study

Who is it for?
Ages 8 to 10 years
Conditions the study is for
Preterm Birth, Child Development
What is being tested?
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
377 participants
Where
1 siteUnited States
Study dates
1 Dec 2021to 30 Jun 2027
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Previous participation in Omega Tots (NCT01576783).
  • Current age of 8 years, 180 days to 10 years, 180 days.

Who cannot join

  • Child in custody of children's services for their window of eligibility

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

Read the detailed description

The overall objective with the present study is to determine the long-term effects of docosahexaenoic acid (DHA) plus arachidonic acid (AA) supplementation on general cognitive ability, language, and executive function, and to examine genetic explanations for treatment effects, through one comprehensive study visit with children and parents from the Omega Tots trial cohort (NCT01576783).

Being tested
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA), Placebo
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)Drug

    200 mg DHA+ 200 mg AA per day for 6 months

  • PlaceboDietary supplement

    400 mg corn oil per day for 6 months

Study groups in NCT05191823
Study groupRoleWhat they receive
Docosahexaenoic Acid + Arachidonic AcidExperimentalDocosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Receives: Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
PlaceboPlacebo comparatorCorn oil supplement
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)

    Differential Ability Scales-II General Conceptual Ability assessment is a measure of general cognitive ability and is used to assess and identify children's cognitive strengths and weaknesses. The general cognitive ability score has a range from 30 to 170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  2. Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth Edition-CELF-5)

    Clinical evaluation of Language Fundamentals, 5th edition core tests is a comprehensive measure of language and can assess children's written and oral language skills, as well as their reading comprehension. The core language score has a range from 30 to 170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  3. Executive Function (NIH Toolbox)

    The NIH Toolbox Cognition Battery is a multi-dimensional set of brief measures assessing cognitive function. The Flanker, Dimensional Card Sort, and Pattern Comparison subtests measure executive function, processing speed, and attention. Standard scores have a range from 30 to 170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance..

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

Secondary outcomes (20)
  1. Grooved Pegboard Task

    The Grooved Pegboard task measures eye-hand coordination and motor speed by requiring children to insert pegs into a board. The score is the time to place the pegs. If the child reaches the time limit of 3 minutes, then the score is the number of pegs placed. A faster time and lower number of pegs dropped is indicative of better performance.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  2. Select Subtest From the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)

    The Weschler Intelligence Scales for Children-V Digit Span and Picture Span subtests assess working memory. The working memory index composite score has a range from 30-170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  3. Select Subtests From the Kaufman Test of Educational Achievement, Third Edition (KTEA-3)

    The Kaufman Test of Educational Achievement-3 is an assessment of key academic skills. The Letter and Word Recognition, Math Computation, Object Naming Facility, and Associative Fluency Subtests measure children's reading, math, and written language skills. The standard score has a range from 30-170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  4. Anthropometrics-Body Composition (Height)

    To assess children's body composition, height (in centimeters) is measured. This is converted to a z score for age and sex 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.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  5. Anthropometrics-Body Composition (Weight)

    To assess children's body composition, weight (in kilograms) is measured. This is converted to a z score for age and sex 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.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  6. Anthropometrics-Adiposity

    To assess children's adiposity, a bioelectric impedance is used to measure body fat percent. Child's height and weight will be combined to report BMI (kg/m^2). These measurements are converted to a z score for age and sex 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.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  7. Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2)

    The Behavior Rating Inventory of Executive Function, 2nd ed., is completed by the child's caregiver and teacher to measure a range of executive functioning capabilities in children. The BRIEF-2 yields nine clinical scales that measure various aspects of executive function plus three broad indices: behavioral regulation, emotion regulation, and cognitive regulation. Scores are summed to obtain a Global Executive Composite Score that will be expressed as a t score (range= [35-90]; (mean=50; SD=10), where a higher score indicates greater dysregulation .

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  8. Select Subscales From the Teacher Report Form 6-18

    The Teacher Report Form (syndrome and DSM-Oriented subscales) is completed by the child's teacher to reflect on the child's behavior in the previous six months. Scores are summed to provide a total problems score. Scores are also computed to measure the following subscales: internalizing problems, externalizing problems, anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggression behavior, affective problems, anxiety problems, somatic problems, attention deficit/hyperactivity problems, oppositional defiant problems, conduct problems. Scores will be expressed as a t-score (range= [33-100]; mean=50; SD=10), where a lower score indicates a more optimal outcome.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  9. Child Behavior Checklist 6-18 (CBCL) - Competence

    The Child Behavior Checklist is completed by the child' caregiver to reflect their child's behavior in the previous six months. Scores were summed to provide total competence score. Total competence scores will be expressed as a t-score (range= [20-100]; mean=50; SD=10), where a higher score reflects a more optimal outcome.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  10. National Survey of Children's Health Module - Learning Disability

    The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report . A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  11. Emotion Regulation Checklist - Emotion Regulation

    The Emotion Regulation Checklist is completed by the child's caregiver to measure child's ability to manage their emotions. Scores are grouped and summed to yield Emotion Regulation scale (range=10-40). Higher scores on the Emotion Regulation scale indicates more ability to regulate

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  12. NIH Toolbox Friendship Fixed Form

    The NIH Toolbox Friendship (Ages 8-17) Fixed Form is a 5-item questionnaire that measures peer relationships and assesses the quality of relationships with friends and other acquaintances over the past month. Scores will be expressed as a t-score (range= [16-68]; mean=50; SD=10), where a higher score indicates stronger peer relationships.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  13. NIH Toolbox Positive Peer Interaction Parent Report Fixed Form

    The NIH Toolbox Positive Peer Interaction Form (Ages 3-12) is a 4-item questionnaire that measures child peer relationships via parent report. Scores will be expressed as a t-score (range= [-8-63] ; mean=50; SD=10), where a higher score indicates stronger peer relationships.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  14. Child Sleep Habits Questionnaire-abbreviated Measure

    The Child Sleep Habits Questionnaire-abbreviated measures child sleep pattern and behaviors via parent report. Parents are asked to report on the child's bedtime behavior, sleep duration, and behavior during sleep. Scores are summed to give the total sleep disturbance score (range 33-99). Scores are also grouped and summed to yield eight subscales that measure different aspects of sleep. A higher score is indicative of more sleep problems .

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  15. Child Behavior Checklist 6-18 (CBCL) - Problems

    The Child Behavior Checklist is completed by the child' caregiver to reflect their child's behavior in the previous six months. Scores were summed to provide problem scores. T Problem scores will be expressed as a t-score (range= [25,100]; mean=50; SD=10), where a lower score reflects a more optimal outcome.

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  16. National Survey of Children's Health Module - Developmental Delay

    The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report . A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  17. National Survey of Children's Health Module - INtellectual Disability

    The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report . A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  18. National Survey of Children's Health Module - Speech or Other Language Disorder

    The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report . A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  19. National Survey of Children's Health Module - Behavioral or Conduct Problems

    The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report . A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

  20. Emotion Regulation Checklist - Lability/Negativity

    The Emotion Regulation Checklist is completed by the child's caregiver to measure child's ability to manage their emotions. Scores are grouped and summed to yield a Lability/Negativity (range=14-56) scale. Higher scores on the Lability/Negativity scale reflect greater dysregulation .

    Measured: A single study visit when the child is between 8.5 years to 10.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start1 Dec 2021
  3. Primary completion25 Jun 2024
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05191823
Sponsor's protocol ID
00001037
Other IDs
R01HD100493
Status last verified
Jul 2026
First submitted
21 Dec 2021
Last updated
11 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Robinette LM, Taylor HG, Boone KM, Rogers LK, Rausch J, Bartlett CW, Klebanoff MA, Keim SA. Fatty Acid Supplementation in Toddlers Born Preterm and Attention and Autism Outcomes at 8-10 Years: Omega Tots Randomized Controlled Trial Long-Term Follow-Up. J Autism Dev Disord. 2026 Oct 22. doi: 10.1007/s10803-026-07566-z. Online ahead of print.

    PubMed 42911477

Questions about this trial

What is this clinical trial studying?

A study testing Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) in people with Preterm Birth and Child Development, run by Sarah Keim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II) (time frame: A single study visit when the child is between 8.5 years to 10.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05191823, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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