Premature, Extremely Low Birth Weight InfantsNCT01955044
PUFA Supplementation in Premature Infants
A study testing LCPUFA supplement in people with Premature, Extremely Low Birth Weight Infants and Polyunsaturated Fatty Acid Levels, run by Endeavor Health at 3 sites in United States.
Trial summary
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants. Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
- What is being tested?
- LCPUFA supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Apr 2016
- 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 Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- a) Premature infant born at gestational age less than 34 weeks
- b) Birth weight less than 1000 grams
- c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures
Who cannot join
- a) infants with known metabolic disorder
- b) infants with known congenital gastrointestinal anomaly
- c) infants who are deemed to be inappropriate for enrollment per attending neonatologist
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Prentice Women's Hospital
Chicago, Illinois, 60611
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: Early DHA Supplementation in Extremely Low Birth Weight Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.
Read the detailed description
This will be a multi-center, randomized, placebo controlled, double blind trial.
Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.
ELBW infants will be enrolled into this study.
- Being tested
- LCPUFA supplement, placebo
- Keywords
- neonatal prematurity, infant, extremely low birth weight, fatty acids, polyunsaturated
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCPUFA supplementDietary supplement
Also called PUFA supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| "high" dose LCPUFA | Experimental | the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. Receives: Dietary Supplement: LCPUFA supplement |
| "low" dose LCPUFA | Experimental | the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. Receives: Dietary Supplement: LCPUFA supplement |
| placebo | Placebo comparator | the "placebo" is a drop that will be administered to ELBW infants. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
Measured: 2 weeks of life
Secondary outcomes (1)
LCPUFA Levels
LCPUFA levels will be measured at 8 weeks of life.
Measured: 8 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2015
- Study completionApr 2016
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 Premature, Extremely Low Birth Weight InfantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, Mead Johnson Nutrition
- Responsible party
- Principal investigator, Brandy Frost, Endeavor Health
- Investigators
- Michael S Caplan, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955044
- Sponsor's protocol ID
- EH13-334
- Status last verified
- Aug 2021
- First submitted
- 27 Sep 2013
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Robinson DT, Caplan M, Carlson SE, Yoder R, Murthy K, Frost B. Early docosahexaenoic and arachidonic acid supplementation in extremely-low-birth-weight infants. Pediatr Res. 2016 Oct;80(4):505-10. doi: 10.1038/pr.2016.118. Epub 2016 Jun 3.
PubMed 27356083
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early DHA Supplementation in Extremely Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01955044
- Acronym / sponsor ID
- EH13-334
- Keywords
- neonatal prematurity, infant, extremely low birth weight, fatty acids, polyunsaturated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, Mead Johnson Nutrition
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Posted 29 Mar 2016
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 determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.
Detailed description
This will be a multi-center, randomized, placebo controlled, double blind trial.
Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.
ELBW infants will be enrolled into this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "high" dose LCPUFA | Experimental | Dietary Supplement: LCPUFA supplementthe "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. |
| "low" dose LCPUFA | Experimental | Dietary Supplement: LCPUFA supplementthe "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. |
| placebo | Placebo comparator | Dietary Supplement: placebothe "placebo" is a drop that will be administered to ELBW infants. |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a) Premature infant born at gestational age less than 34 weeks
- b) Birth weight less than 1000 grams
- c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures
Key exclusion criteria (3 listed)
- a) infants with known metabolic disorder
- b) infants with known congenital gastrointestinal anomaly
- c) infants who are deemed to be inappropriate for enrollment per attending neonatologist
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 supplementAlso: PUFA supplement | Dietary supplement | "high" dose LCPUFA, "low" dose LCPUFA |
| placebo | Dietary supplement | placebo |
Primary outcome
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
Time frame: 2 weeks of life
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
1 secondary outcome
LCPUFA Levels
Time frame: 8 weeks of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27356083Robinson DT, Caplan M, Carlson SE, Yoder R, Murthy K, Frost B. Early docosahexaenoic and arachidonic acid supplementation in extremely-low-birth-weight infants. Pediatr Res. 2016 Oct;80(4):505-10. doi: 10.1038/pr.2016.118. Epub 2016 Jun 3.
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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.
Michael S Caplan, MD principal investigator
Endeavor Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCPUFA supplement in people with Premature, Extremely Low Birth Weight Infants and Polyunsaturated Fatty Acid Levels, run by Endeavor Health at 3 sites 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 3 inclusion and 3 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 29 Mar 2016). 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?
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels (time frame: 2 weeks of life). 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 NCT01955044, 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 5 Sep 2021.