Infant MalnutritionNCT06207071
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
A study testing DHA in people with Infant Malnutrition and Light-For-Dates With Signs of Fetal Malnutrition, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation… Read more about this study
- Who is it for?
- Ages 24 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature
- What is being tested?
- DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to Apr 2027
- 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 24 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational ages between 22 0/7 - 32 6/7 weeks gestation
- < 25th centile birthweight
Who cannot join
- Major congenital/chromosomal anomalies
- Terminal illness in which decisions to withhold or limit support have been made
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.
- Conditions
- Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant
- Being tested
- DHA
- Medical subject headings
- Infant Nutrition Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADietary supplement
DHA supplementation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | A DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth. Receives: Dietary Supplement: DHA |
| Control | No intervention | No DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head circumference at 36 weeks postmenstrual age or discharge
Declines in head circumference z scores from birth to 36 weeks postmenstrual age
Measured: Birth to 36 weeks postmenstrual age or discharge
Secondary outcomes (2)
Fat mass(FM)-for-age Z-score
FM accretion will be estimated by air displacement plethysmography
Measured: Birth to 36 weeks postmenstrual age
Changes in serum metabolic profile at 36 weeks postmenstrual age
Determined by metabolomic analyses of serum samples
Measured: 36 weeks postmenstrual age or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start20 May 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant MalnutritionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207071
- Sponsor's protocol ID
- IRB-300012038
- Other IDs
- 8726
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06207071
- Acronym / sponsor ID
- IRB-300012038
- Conditions
- Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- 20 May 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Jan 2024 (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.
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: DHAA DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth. |
| Control | No intervention | –No DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth. |
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational ages between 22 0/7 - 32 6/7 weeks gestation
- < 25th centile birthweight
Key exclusion criteria (2 listed)
- Major congenital/chromosomal anomalies
- Terminal illness in which decisions to withhold or limit support have been made
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 |
|---|---|---|
| DHADHA supplementation | Dietary supplement | Intervention |
Primary outcome
Head circumference at 36 weeks postmenstrual age or discharge
Time frame: Birth to 36 weeks postmenstrual age or discharge
Declines in head circumference z scores from birth to 36 weeks postmenstrual age
2 secondary outcomes
Fat mass(FM)-for-age Z-score
Time frame: Birth to 36 weeks postmenstrual age
Changes in serum metabolic profile at 36 weeks postmenstrual age
Time frame: 36 weeks postmenstrual age or discharge
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 16 Oct 2026.
Related trials for Infant Malnutrition
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Not yet recruitingPhase 4
Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
Iodine Deficiency, Nutrition Poor
Active, not recruitingObservational study
Microbiome and Malnutrition in Pregnancy
Pregnancy Related, Pregnancy Loss
Active, not recruitingPhase 1
Slow Introduction of Nutrition for Ill Malnourished Children
Malnutrition, Severe Acute, Malnutrition, Child
Recruiting
Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
Malnutrition (Calorie), Infant Nutrition Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA in people with Infant Malnutrition and Light-For-Dates With Signs of Fetal Malnutrition, run by University of Alabama at Birmingham 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 2 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 16 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 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. 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?
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?
Head circumference at 36 weeks postmenstrual age or discharge (time frame: Birth to 36 weeks postmenstrual age or discharge). 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.