Preterm BirthPhase 4NCT01683565

Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

A Phase 4 study testing LCPUFA oil supplement in people with Preterm Birth and Child Development, run by Sarah Keim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm. Read more about this study

Who is it for?: Ages 18 to 39 months
Conditions the study is for: Preterm Birth, Child Development, Child Behavior
What is being tested?: LCPUFA oil supplement
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteUnited States
Study dates: Sep 2012to Jan 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 18 to 39 months
All sexes
No healthy volunteers
Child

Who may be able to join

Child born at less than or equal to 29 completed weeks' gestation;
Child between 18 months, 0 days and 38 months, 30 days old chronological age;
Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.
Child showing some autistic symptoms;
Child between the 5th and 95th percentiles (per WHO growth chart) for weight at his/her most recent hospital visit;
English spoken in the home, demonstrate ability to communicate in English well-enough to understand study, informed consent, and study questionnaires; and
Have informed consent on file.

Who cannot join

Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x per week;
Unable to tolerate venipuncture;
Any major malformation that would preclude participation;
Cerebral Palsy (quadriparesis only);
Deafness;
Blindness;

Show all 14Show fewer

Bleeding disorder;
Type I diabetes;
Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis;
Non febrile seizure in the last month without a clear and resolved etiology;
Feeding problem that may inhibit full participation;
Known fish allergy;
Known canola/rapeseed allergy or sensitivity; or
Recorded score of <70 on Bayley Cognitive Section within the past year.

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

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.

Conditions: Preterm Birth, Child Development, Child Behavior
Being tested: LCPUFA oil supplement, Canola Oil Placebo
Medical subject headings: Premature Birth, Child Behavior

What participants receive

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

LCPUFA oil supplementDrug
2.5mL per day for 90 days
Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)
Canola Oil PlaceboOther
2.5mL per day for 90 days

Study groups in NCT01683565
Study group	Role	What they receive
LCPUFA Oil Supplement	Experimental	EPA + DHA + GLA + OA oil supplement Receives: Drug: LCPUFA oil supplement
Canola Oil Placebo	Placebo comparator	Not described Receives: Other: Canola Oil Placebo

What is being measured

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

Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2
The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline.
Measured: Baseline to 90 days post randomization
Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline.
Measured: Baseline to 90 days post randomization

Secondary outcomes (1)

Fatty Acid
The secondary outcome measures in this trial involve an examination of change in fatty acids from the first study visit to the final study visit.
Measured: Baseline to 90 days post randomization

Timeline

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

Sep 2012Jan 2017

First posted12 Sep 2012 (estimated)
Study startSep 2012
Primary completionMar 2015
Study completionJan 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 (3)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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01683565
Sponsor's protocol ID: 752311
Status last verified: Dec 2018
First submitted: 4 Sep 2012
Last updated: 3 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Effects of Omega-3-6-9 fatty acid supplementation on behavior and sleep in preterm toddlers with autism symptomatology: Secondary analysis of a randomized clinical trial. Early Hum Dev. 2022 Jun;169:105588. doi: 10.1016/j.earlhumdev.2022.105588. Epub 2022 May 19.
PubMed 35644107
Keim SA, Gracious B, Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Sheppard KW, Husk J, Rhoda DA. omega-3 and omega-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers. J Nutr. 2018 Feb 1;148(2):227-235. doi: 10.1093/jn/nxx047.
PubMed 29490101
Boone KM, Gracious B, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Omega-3 and -6 fatty acid supplementation and sensory processing in toddlers with ASD symptomology born preterm: A randomized controlled trial. Early Hum Dev. 2017 Dec;115:64-70. doi: 10.1016/j.earlhumdev.2017.09.015. Epub 2017 Sep 20.
PubMed 28941976

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Preterm Birth trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
ClinicalTrials.gov ID: NCT01683565
Acronym / sponsor ID: 752311
Conditions: Preterm Birth, Child Development, Child Behavior
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Sarah KeimUniversity, hospital or other
Collaborators: Cures Within Reach, Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
Study start: Sep 2012 (actual)
Primary completion: Mar 2015 (actual)
Study completion: Jan 2017 (actual)
First posted: 12 Sep 2012 (estimated)
Results: Posted 3 Jan 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 development and behavior 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
LCPUFA Oil Supplement	Experimental	Drug: LCPUFA oil supplementEPA + DHA + GLA + OA oil supplement
Canola Oil Placebo	Placebo comparator	Other: Canola Oil Placebo

Who may qualify

Ages: 18 to 39 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Child born at less than or equal to 29 completed weeks' gestation;
Child between 18 months, 0 days and 38 months, 30 days old chronological age;
Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.
Child showing some autistic symptoms;
Child between the 5th and 95th percentiles (per WHO growth chart) for weight at his/her most recent hospital visit;

Key exclusion criteria (14 listed)

Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x per week;
Unable to tolerate venipuncture;
Any major malformation that would preclude participation;
Cerebral Palsy (quadriparesis only);
Deafness;

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
LCPUFA oil supplement2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)	Drug	LCPUFA Oil Supplement
Canola Oil Placebo2.5mL per day for 90 days	Other	Canola Oil Placebo

Primary outcome

Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2
Time frame: Baseline to 90 days post randomization
The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline.
Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
Time frame: Baseline to 90 days post randomization
Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline.

1 secondary outcome

Fatty Acid
Time frame: Baseline to 90 days post randomization

Results and safety

Results posted to the registry on 3 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement	15	12
Canola Oil Placebo	16	15

Primary outcome: Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2

Time frame: Baseline to 90 days post randomization. Mean (Standard Deviation). Unit: score on a scale

Measure	Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement n = 15	Canola Oil Placebo n = 16
Value	-1.0 (2.6)	-0.2 (1.9)

Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement vs Canola Oil Placebo: p = 0.67, Mixed Models Analysis

Primary outcome: Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)

Time frame: Baseline to 90 days post randomization. Mean (Standard Deviation). Unit: score on a scale

Measure	Long Chain Polyunsaturated Fatty Acids (LCPUFA) Supplement n = 15	Canola Oil Placebo n = 16
Competence	1.9 (3.2)	0.9 (3.6)
Problems	3.2 (6.1)	-3.2 (5.0)
Dysregulation	-0.9 (2.3)	-0.8 (2.2)
Externalizing	0.3 (1.3)	-0.7 (2.3)
Internalizing	-0.9 (2.3)	-0.5 (2.3)
Austism Spectrum Disorder	-1.5 (2.6)	0.8 (3.8)
Red Flag	-2.5 (3.8)	-1.0 (2.8)

Long Chain Polyunsaturated Fatty Acids (LCPUFA) Supplement vs Canola Oil Placebo: p = 0.22, Mixed Models Analysis
Long Chain Polyunsaturated Fatty Acids (LCPUFA) Supplement vs Canola Oil Placebo: p = 0.92, Mixed Models Analysis
Long Chain Polyunsaturated Fatty Acids (LCPUFA) Supplement vs Canola Oil Placebo: p = 0.88, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to 90 days post randomization. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCPUFA Oil Supplement	0 of 15 (0%)	15 of 15 (100%)	0 of 15
Canola Oil Placebo	0 of 16 (0%)	16 of 16 (100%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35644107Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Effects of Omega-3-6-9 fatty acid supplementation on behavior and sleep in preterm toddlers with autism symptomatology: Secondary analysis of a randomized clinical trial. Early Hum Dev. 2022 Jun;169:105588. doi: 10.1016/j.earlhumdev.2022.105588. Epub 2022 May 19.
Derived from this study: PubMed 29490101Keim SA, Gracious B, Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Sheppard KW, Husk J, Rhoda DA. omega-3 and omega-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers. J Nutr. 2018 Feb 1;148(2):227-235. doi: 10.1093/jn/nxx047.
Derived from this study: PubMed 28941976Boone KM, Gracious B, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Omega-3 and -6 fatty acid supplementation and sensory processing in toddlers with ASD symptomology born preterm: A randomized controlled trial. Early Hum Dev. 2017 Dec;115:64-70. doi: 10.1016/j.earlhumdev.2017.09.015. Epub 2017 Sep 20.

Related trials for Preterm Birth

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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 LCPUFA oil supplement 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 7 inclusion and 14 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 3 Jan 2019. 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 3 Jan 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?

Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 (time frame: Baseline to 90 days post randomization). The study lists 2 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 NCT01683565, which also lists 3 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 3 Jan 2019.