Preterm BirthPhase 4NCT01576783
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
A Phase 4 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
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm. Read more about this study
- Who is it for?
- Ages 10 to 16 months
- 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
- 26 Apr 2012to 6 Apr 2017
- Phase
- Phase 4
- 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 10 to 16 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
- 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.
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
Measured: Baseline to 180 days post-randomization
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
Measured: Baseline to 180 days post-randomization
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.
Measured: Baseline to 180 days post-randomization
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
Measured: Baseline to 180 days post-randomization
Secondary outcomes (2)
(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).
Measured: Baseline to 180 days post-randomization
(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
Measured: Baseline to 180 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study start26 Apr 2012
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
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 (5)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Keim
- Sponsor type
- University, hospital or other
- Collaborators
- Allen Foundation Inc., March of Dimes, Cures Within Reach, Health Resources and Services Administration (HRSA)
- 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
- NCT01576783
- Sponsor's protocol ID
- 183210
- Status last verified
- Jun 2021
- First submitted
- 10 Apr 2012
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33768637Sullivan 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.
PubMed 31984781Boone 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.
PubMed 31538590Boone 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.
PubMed 30579584Keim 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.
PubMed 30357263
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
- ClinicalTrials.gov ID
- NCT01576783
- Acronym / sponsor ID
- 183210
- Conditions
- Preterm Birth, Child Development
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Sarah KeimUniversity, hospital or other
- Collaborators
- Allen Foundation Inc., March of Dimes, Cures Within Reach, Health Resources and Services Administration (HRSA)
- Study start
- 26 Apr 2012 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Posted 24 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, 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
- 10 to 16 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
Erythrocyte Fatty Acid Levels
Time frame: Baseline to 180 days post-randomization
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)
Time frame: Baseline to 180 days post-randomization
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
Time frame: Baseline to 180 days post-randomization
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
Time frame: Baseline to 180 days post-randomization
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
2 secondary outcomes
(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
Time frame: Baseline to 180 days post-randomization
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Time frame: Baseline to 180 days post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33768637Boone 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.
- Derived from this study: PubMed 31984781Sullivan 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.
- Derived from this study: PubMed 31538590Boone 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.
- Derived from this study: PubMed 30579584Boone 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.
- Derived from this study: PubMed 30357263Keim 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.
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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 Phase 4 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jun 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2019). 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?
Erythrocyte Fatty Acid Levels (time frame: Baseline to 180 days post-randomization). The study lists 4 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 NCT01576783, which also lists 5 linked publications.
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 29 Jun 2021.