PrematureNCT05380401
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
A study testing Enfamil® DHA & ARA Supplement for Special Dietary Use in people with Premature, run by The University of Texas Health Science Center at San Antonio at 7 sites in United States.
Trial summary
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Premature
- What is being tested?
- Enfamil® DHA & ARA Supplement for Special Dietary Use
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Mar 2023to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born between 25 0/7 and 29 6/7 weeks of gestation
- less than 48 hours of age at first lipid dose (The cohort is defined by gestational age rather than birth weight to avoid an over-represented sample of growth-restricted infants in birth weight defined cohorts.)
Who cannot join
- serious congenital anomalies
- conditions at birth that will require surgery prior to discharge
- imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Daniel Robinson, MD, DTRobinson@luriechildrens.org
Jonah Silverglade, jsilverglade@luriechildrens.org
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Daniel Robinson, MD, DTRobinson@luriechildrens.org
Jonah Silverglade, jsilverglade@luriechildrens.org
- Recruiting
University of California, Los Angeles (UCLA)
Los Angeles, California, 90404
Kara Calkins, MD, KCalkins@mednet.ucla.edu
Ashley Dong, AMDong@mednet.ucla.edu
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06511
Sarah Taylor, MD, sarah.n.taylor@yale.edu
Tessa Kehoe, tessa.kehoe@yale.edu
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Camilia Martin, MD, camilia.martin@med.cornell.edu
Martha Liu, mal4038@med.cornell.edu
- Recruiting
University Health System
San Antonio, Texas, 78229
Diana Anzueto Guerra, MS, 210-567-5254, anzuetod@uthscsa.edu
Cynthia Blanco, MD, 210-567-5225, blanco@uthscsa.edu
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Cynthia Blanco, MD, blanco@uthscsa.edu
Diana Anzueto Guerra, anzuetod@uthscsa.edu
About this study
Official title: Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.
Read the detailed description
Infants will be randomized to receive the combined enteral DHA/ARA supplement within the first 48 hours after birth to 36 weeks postmenstrual age. The randomization procedure will follow a stratified permuted block scheme to fulfill two goals: (1) randomize infants into one of four arms and (2) ensure an adequate sample size within each week of gestational age. Preterm infants will be randomized using random permuted blocks within each of the 5 birth gestational age strata. When treatment assignment is open and sample size is not overtly large, a block randomization procedure with randomly chosen block sizes can maintain treatment assignment balance and reduce the potential for selection bias. This approach will also ensure that preterm infants of all eligible gestational ages at birth are approximately equally represented in each of 4 arms of the trial, thus ensuring that important comorbidities and standard of care applicable to infants of different gestational ages at birth are also approximately equally distributed across the study arms. There is no placebo for this study. There is no blinding in this study. Consent will also be obtained from the mother of the infant, as they will be asked to provide milk samples if they're breastfeeding their infant, and maternal medical history and demographical data will be recorded.
- Conditions
- Premature
- Being tested
- Enfamil® DHA & ARA Supplement for Special Dietary Use
- Keywords
- infant, premature, fatty acids, nutrition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfamil® DHA & ARA Supplement for Special Dietary UseDietary supplement
Also called DHA/ARA Supplement
Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe
| Study group | Role | What they receive |
|---|---|---|
| DHA/ARA supplement | Other | DHA/ARA supplement throughout the duration of the protocol, "d-on" Receives: Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use |
| No DHA/ARA supplement | No intervention | no DHA/ARA supplement throughout the duration of the protocol, "d-off" |
| DHA/ARA initially then no supplement | Other | DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off" Receives: Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use |
| No supplement initially then DHA/ARA supplement | Other | No DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on" Receives: Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid levels in plasma
Change in lipid metabolites reflected by levels in plasma
Measured: Baseline to 36 weeks
Fatty acid levels in red blood cell (RBC) membranes
Change in fatty acid levels in RBC membranes
Measured: Baseline to 36 weeks
Change in circulating biomarker Lipoxin A4
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Measured: Baseline to 36 weeks
Change in biomarker Resolvin D1
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Measured: Baseline to 36 weeks
Change in biomarker Resolvin E1
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Measured: Baseline to 36 weeks
Change in Protectin/Neuroprotectin
Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.
Measured: Baseline to 36 weeks
Secondary outcomes (1)
Change in infant weigh
Recorded in grams (ounces)
Measured: Baseline to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start9 Mar 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be four arms of the trial encompassing the period from enrollment to 36 weeks' postmenstrual age: (a) DHA/ARA supplement throughout the duration of the protocol, "d-on"; (b) no DHA/ARA supplement throughout the duration of the protocol, "d-off"; (c) a cross-over arm of DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off"; and (d) a cross-over arm of no DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on".
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Cynthia Blanco, MD, MSCI-TS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380401
- Sponsor's protocol ID
- HSC20220120H
- Other IDs
- 1R01HD108646
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared with the funding body, NIH, summary results will be shared in ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants
- ClinicalTrials.gov ID
- NCT05380401
- Acronym / sponsor ID
- HSC20220120H
- Conditions
- Premature
- Keywords
- infant, premature, fatty acids, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.
Detailed description
Infants will be randomized to receive the combined enteral DHA/ARA supplement within the first 48 hours after birth to 36 weeks postmenstrual age. The randomization procedure will follow a stratified permuted block scheme to fulfill two goals: (1) randomize infants into one of four arms and (2) ensure an adequate sample size within each week of gestational age. Preterm infants will be randomized using random permuted blocks within each of the 5 birth gestational age strata. When treatment assignment is open and sample size is not overtly large, a block randomization procedure with randomly chosen block sizes can maintain treatment assignment balance and reduce the potential for selection bias. This approach will also ensure that preterm infants of all eligible gestational ages at birth are approximately equally represented in each of 4 arms of the trial, thus ensuring that important comorbidities and standard of care applicable to infants of different gestational ages at birth are also approximately equally distributed across the study arms. There is no placebo for this study. There is no blinding in this study. Consent will also be obtained from the mother of the infant, as they will be asked to provide milk samples if they're breastfeeding their infant, and maternal medical history and demographical data will be recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There will be four arms of the trial encompassing the period from enrollment to 36 weeks' postmenstrual age: (a) DHA/ARA supplement throughout the duration of the protocol, "d-on"; (b) no DHA/ARA supplement throughout the duration of the protocol, "d-off"; (c) a cross-over arm of DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off"; and (d) a cross-over arm of no DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on".
| Arm | Type | Receives |
|---|---|---|
| DHA/ARA supplement | Other | Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary UseDHA/ARA supplement throughout the duration of the protocol, "d-on" |
| No DHA/ARA supplement | No intervention | –no DHA/ARA supplement throughout the duration of the protocol, "d-off" |
| DHA/ARA initially then no supplement | Other | Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary UseDHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off" |
| No supplement initially then DHA/ARA supplement | Other | Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary UseNo DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on" |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- born between 25 0/7 and 29 6/7 weeks of gestation
- less than 48 hours of age at first lipid dose (The cohort is defined by gestational age rather than birth weight to avoid an over-represented sample of growth-restricted infants in birth weight defined cohorts.)
Key exclusion criteria (3 listed)
- serious congenital anomalies
- conditions at birth that will require surgery prior to discharge
- imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth
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 |
|---|---|---|
| Enfamil® DHA & ARA Supplement for Special Dietary UseAlso: DHA/ARA SupplementDosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe | Dietary supplement | DHA/ARA initially then no supplement, DHA/ARA supplement, No supplement initially then DHA/ARA supplement |
Primary outcome
Fatty acid levels in plasma
Time frame: Baseline to 36 weeks
Change in lipid metabolites reflected by levels in plasma
Fatty acid levels in red blood cell (RBC) membranes
Time frame: Baseline to 36 weeks
Change in fatty acid levels in RBC membranes
Change in circulating biomarker Lipoxin A4
Time frame: Baseline to 36 weeks
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Change in biomarker Resolvin D1
Time frame: Baseline to 36 weeks
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Change in biomarker Resolvin E1
Time frame: Baseline to 36 weeks
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Change in Protectin/Neuroprotectin
Time frame: Baseline to 36 weeks
Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.
1 secondary outcome
Change in infant weigh
Time frame: Baseline to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with the funding body, NIH, summary results will be shared in ClinicalTrials.gov
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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.
Cynthia Blanco, MD, MSCI-TS principal investigator
The University of Texas Health Science Center at San Antonio
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enfamil® DHA & ARA Supplement for Special Dietary Use in people with Premature, run by The University of Texas Health Science Center at San Antonio at 7 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 2 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Blanco, MD, MSCI-TS (210-567-5225, blanco@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acid levels in plasma (time frame: Baseline to 36 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.