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.
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
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).
- Conditions
- Preterm Birth, Child Development
- 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 group | Role | What they receive |
|---|---|---|
| Docosahexaenoic Acid + Arachidonic Acid | Experimental | Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) Receives: Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) |
| Placebo | Placebo comparator | Corn oil supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted14 Jan 2022
- Study start1 Dec 2021
- Primary completion25 Jun 2024
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sarah Keim
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Sarah Keim, Nationwide Children's Hospital
- Investigators
- Sarah Keim, PhD, Principal investigator, Nationwide Children's Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
- ClinicalTrials.gov ID
- NCT05191823
- Acronym / sponsor ID
- 00001037
- Conditions
- Preterm Birth, Child Development
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Sarah KeimUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosahexaenoic Acid + Arachidonic Acid | Experimental | Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCorn oil supplement |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Previous participation in Omega Tots (NCT01576783).
- Current age of 8 years, 180 days to 10 years, 180 days.
Key exclusion criteria (1 listed)
- Child in custody of children's services for their window of eligibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)200 mg DHA+ 200 mg AA per day for 6 months | Drug | Docosahexaenoic Acid + Arachidonic Acid |
| Placebo400 mg corn oil per day for 6 months | Dietary supplement | Placebo |
Primary outcome
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
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.
Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth Edition-CELF-5)
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
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.
Executive Function (NIH Toolbox)
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
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..
20 secondary outcomes
Grooved Pegboard Task
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Select Subtest From the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Select Subtests From the Kaufman Test of Educational Achievement, Third Edition (KTEA-3)
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Anthropometrics-Body Composition (Height)
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Anthropometrics-Body Composition (Weight)
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Anthropometrics-Adiposity
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2)
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Select Subscales From the Teacher Report Form 6-18
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Child Behavior Checklist 6-18 (CBCL) - Competence
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
National Survey of Children's Health Module - Learning Disability
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Emotion Regulation Checklist - Emotion Regulation
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
NIH Toolbox Friendship Fixed Form
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
NIH Toolbox Positive Peer Interaction Parent Report Fixed Form
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Child Sleep Habits Questionnaire-abbreviated Measure
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Child Behavior Checklist 6-18 (CBCL) - Problems
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
National Survey of Children's Health Module - Developmental Delay
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
National Survey of Children's Health Module - INtellectual Disability
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
National Survey of Children's Health Module - Speech or Other Language Disorder
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
National Survey of Children's Health Module - Behavioral or Conduct Problems
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Emotion Regulation Checklist - Lability/Negativity
Time frame: A single study visit when the child is between 8.5 years to 10.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42911477Robinette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Keim, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
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.