Study Results
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.
ACTIVE_NOT_RECRUITING
NA
102 participants
INTERVENTIONAL
2021-05-27
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Exclusive Enteral Nutrition in Early Preterm Infants
NCT03708068
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
NCT07045844
Effect of Increased Enteral Protein on Body Composition of Preterm Infants
NCT03586102
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
NCT04325308
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
NCT01766011
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Intervention group: Feeds will be initiated with a target volume of 60-80 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150ml/kg/day is achieved.
Control group: Enteral feeds will be initiated with a target volume of 20-30 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150 ml/kg/day is achieved.
If parent agrees, stool "dirty" diapers will be collected 2 times during this study.
One time around the time of birth and one time at 28 days or discharge (whichever occurs first).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exclusive Enteral Nutrition
This group will receive enteral feeding volumes at a rate of 60-80 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day.
Exclusive Enteral Nutrition
Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
Progressive Enteral Nutrition
This group will receive enteral feeding volumes at a rate of 20-30 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day.
Progressive Enteral Nutrition
Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exclusive Enteral Nutrition
Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
Progressive Enteral Nutrition
Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Major congenital or chromosomal anomalies
* Terminal illness in which decisions to withhold or limit support have been made
1 Hour
48 Hours
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ariel A. Salas
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vivek Shukla, MD
Role: STUDY_CHAIR
University of Alabama at Birmingham
Ariel Salas, MD, MSPH
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Jacqueline Razzaghy, MD
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, Salas AA. Early and exclusive enteral nutrition in infants born very preterm. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):378-383. doi: 10.1136/archdischild-2023-325969.
Salas AA, Stewart CJ, Young GR. Early gut microbiome composition of very preterm infants randomised to receive human milk volumes of 60 ml/kg/day or more within the first 36 hours after birth. Pediatr Res. 2025 Oct 2. doi: 10.1038/s41390-025-04456-5. Online ahead of print.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
300004922
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.