MedDataX Logo

High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants

NCT ID: NCT07307612

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2029-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extreme Prematurity Enteral Nutrition Bronchopulmonary Dysplasia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Prematurity; Extreme

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Following written informed consent, participants are assigned in a 2:1 ratio to either the intervention (supplementation) or control (standard diet) group.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
To maintain trial integrity, nutrition room staff that are independent of clinical care will prepare the feeding syringes without DHA/ARA labels to ensure clinicians, parents, and evaluators remain masked.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High-energy Group

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.

Group Type ACTIVE_COMPARATOR

High-energy group

Intervention Type DIETARY_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 Group

The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days.

Group Type OTHER

Standard-energy group

Intervention Type OTHER

Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-energy group

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.

Intervention Type DIETARY_SUPPLEMENT

Standard-energy group

Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gestational age ≤ 28 weeks of gestation
* Postnatal age \< 72 hours

Exclusion Criteria

* Congenital malformations
* Chromosomal anomalies
* Terminal illness needing to limit or withhold support
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ariel A. Salas

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ariel A. Salas, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ariel A. Salas, MD, MSPH

Role: CONTACT

Phone: 205-934-4680

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-300016002

Identifier Type: -

Identifier Source: org_study_id