An interventional study of DHA in Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition and Premature, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to participants aged 24 Hours to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 15 studies in Infant Nutrition Disorders with a site in United States — 3 open to participants now, 8 under way, none of them phase 3. Infant Nutrition Disorders · United States.
Among the 15 studies in Infant Nutrition Disorders with a site in United States, this one is the 5th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2024, is one of 10 with no phase, and was the 14th registered.
67 studies on the registry are indexed under Infant Nutrition Disorders; 14 are open to participants now.
Browse Infant Nutrition Disorders studies →3 of the 15 studies in Infant Nutrition Disorders with a site in United States are open now. Recruiting first, the newest first:
Nemours Children's Clinic · Sites in United States
Ages 1 wk–10 wk · Healthy volunteers
Columbia University · Sites in United States
Ages 1 days–21 days
Pennington Biomedical Research Center · Sites in United States
Ages 1 mo–3 mo · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Infant Nutrition Disorders studies recruiting now, none (0%) set no upper age limit and 11 (100%) stop at 75 or younger; 9 take children under 18; 5 take healthy volunteers.
This study: 24 Hours to 72 Hours · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 152 is below the median of 180 across 46 interventional studies indexed under Infant Nutrition Disorders.
Median enrollment 130 across the 11 interventional studies, 73 across the 4 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 15 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 1 study filed under Infant Nutrition Disorders — fewer than ten, so there is no comparison to draw.
6 of the studies in Infant Nutrition Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04294368Columbia UniversityTargeted Fortification of Donor Breast Milk in Preterm Infants | 2027-03 |
| NCT06117631University of Texas at AustinProject Sueño: Sleep & Understanding Early Nutrition in Obesity | 2027-03-31 |
| NCT06207071University of Alabama at BirminghamEarly DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial | 2027-04 |
| NCT02683473Pennington Biomedical Research CenterMeasurement of Energy Metabolism in Infants | 2027-06-30 |
| NCT04599010Nemours Children's ClinicRole of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty | 2027-07-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 15 studies in Infant Nutrition Disorders with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.
Dietary Supplement: DHA
No DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.
DHA supplementation
Head circumference at 36 weeks postmenstrual age or discharge
Declines in head circumference z scores from birth to 36 weeks postmenstrual age
Time frame: Birth to 36 weeks postmenstrual age or discharge
Fat mass(FM)-for-age Z-score
FM accretion will be estimated by air displacement plethysmography
Time frame: Birth to 36 weeks postmenstrual age
Changes in serum metabolic profile at 36 weeks postmenstrual age
Determined by metabolomic analyses of serum samples
Time frame: 36 weeks postmenstrual age or discharge
Cognitive outcomes
Determined by Bayley assessment
Time frame: 2 years of age
Started May 2024 (actual). Primary completion is estimated for Apr 2027, 35 months after the start.
Of 25 interventional studies with no phase under Infant Nutrition Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 27. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham →