Extreme PrematurityPhase 1/2MEND-BPDNCT07307612
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
A Phase 1/2 study testing High-energy group and Standard-energy group in people with Extreme Prematurity and Enteral Nutrition, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation). Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
- What is being tested?
- High-energy group and Standard-energy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to 31 Jul 2029
- Phase
- Phase 1/2
- 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 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≤ 28 weeks of gestation
- Postnatal age < 72 hours
Who cannot join
- Congenital malformations
- Chromosomal anomalies
- Terminal illness needing to limit or withhold support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Ariel A. Salas, MD, MSPH, 205-934-4680, asalas@uab.edu
About this study
Official title: Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).
Read the detailed description
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a docosahexaenoic acid/arachidonic acid (DHA/ARA)-enriched, fortified human milk diet (intervention group) or a standard fortified human milk diet (control group) during the first 14 days after birth.
- Being tested
- High-energy group, Standard-energy group
- Keywords
- Prematurity; Extreme
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-energy groupDietary supplement
Study participants assigned to the intervention group will receive a standard, fortified human milk diet plus a DHA/ARA supplement during the first 2 weeks after birth.
Standard-energy groupOther
Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.
| Study group | Role | What they receive |
|---|---|---|
| High-energy Group | Active comparator | The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days. Infants in this group will be secondarily assigned to either a low-dose (60/120 mg/kg/day) or high-dose (120/240 mg/kg/day) DHA/ARA supplement. Receives: Dietary Supplement: High-energy group |
| Standard-energy Group | Other | The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days. Receives: Other: Standard-energy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of respiratory morbidity
A scoring system that defines severity of respiratory morbidity (bronchopulmonary dysplasia severity) based on the amount of ventilatory support and the need for supplemental oxygen at 36 weeks postmenstrual age using the Jensen criteria, an ordinal scale ranging from 0 (no respiratory support) to 1 (mild BPD: low-flow nasal cannula ≤2 L/min requirement); 2 (moderate BPD: non-invasive respiratory support, including high-flow nasal cannula >2 L/min, CPAP, or non-invasive positive pressure ventilation); 3 (severe BPD - invasive mechanical ventilation); or 4 (death), with progressively higher scores indicating increasing respiratory morbidity and worse clinical outcomes.
Measured: 0 - 120 days
Non-invasive impulse oscillometry measurements of pulmonary mechanics
Using the N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
Measured: 40 - 120 days
Secondary outcomes (1)
Bronchopulmonary dysplasia
Defined as the need for ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age
Measured: 40 - 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start21 Sep 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme PrematurityStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following written informed consent, participants are assigned in a 2:1 ratio to either the intervention (supplementation) or control (standard diet) group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
- Investigators
- Ariel A. Salas, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307612
- Sponsor's protocol ID
- IRB-300016002
- Other IDs
- R34HL183268
- Acronym
- MEND-BPD
- Status last verified
- Sep 2026
- First submitted
- 24 Dec 2025
- Last updated
- 24 Sep 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial
- ClinicalTrials.gov ID
- NCT07307612
- Acronym / sponsor ID
- MEND-BPD / IRB-300016002
- Keywords
- Prematurity; Extreme
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 29 Dec 2025 (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.
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).
Detailed description
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a docosahexaenoic acid/arachidonic acid (DHA/ARA)-enriched, fortified human milk diet (intervention group) or a standard fortified human milk diet (control group) during the first 14 days after birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Following written informed consent, participants are assigned in a 2:1 ratio to either the intervention (supplementation) or control (standard diet) group.
| Arm | Type | Receives |
|---|---|---|
| High-energy Group | Active comparator | Dietary Supplement: High-energy groupThe intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days. Infants in this group will be secondarily assigned to either a low-dose (60/120 mg/kg/day) or high-dose (120/240 mg/kg/day) DHA/ARA supplement. |
| Standard-energy Group | Other | Other: Standard-energy groupThe control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age ≤ 28 weeks of gestation
- Postnatal age < 72 hours
Key exclusion criteria (3 listed)
- Congenital malformations
- Chromosomal anomalies
- Terminal illness needing to limit or withhold support
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 |
|---|---|---|
| High-energy groupStudy participants assigned to the intervention group will receive a standard, fortified human milk diet plus a DHA/ARA supplement during the first 2 weeks after birth. | Dietary supplement | High-energy Group |
| Standard-energy groupStudy participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth. | Other | Standard-energy Group |
Primary outcome
Severity of respiratory morbidity
Time frame: 0 - 120 days
A scoring system that defines severity of respiratory morbidity (bronchopulmonary dysplasia severity) based on the amount of ventilatory support and the need for supplemental oxygen at 36 weeks postmenstrual age using the Jensen criteria, an ordinal scale ranging from 0 (no respiratory support) to 1 (mild BPD: low-flow nasal cannula ≤2 L/min requirement); 2 (moderate BPD: non-invasive respiratory support, including high-flow nasal cannula >2 L/min, CPAP, or non-invasive positive pressure ventilation); 3 (severe BPD - invasive mechanical ventilation); or 4 (death), with progressively higher scores indicating increasing respiratory morbidity and worse clinical outcomes.
Non-invasive impulse oscillometry measurements of pulmonary mechanics
Time frame: 40 - 120 days
Using the N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
1 secondary outcome
Bronchopulmonary dysplasia
Time frame: 40 - 120 days
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 24 Sep 2026.
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Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
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Effects of Transitional Circulation in ELBW Infants
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Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
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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.
Ariel A. Salas, MD, MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High-energy group and Standard-energy group in people with Extreme Prematurity and Enteral Nutrition, 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 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 24 Sep 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ariel A. Salas, MD, MSPH (205-934-4680, asalas@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of respiratory morbidity (time frame: 0 - 120 days). 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?
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 24 Sep 2026.