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Showing 1–24 of 32 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Necrotizing Enterocolitis of Newborn Clear all
Completed Phase 1 Interventional Results available

Metronidazole Pharmacokinetics (PK) in Premature Infants

NCT01222585
View directory record Official record
Conditions
Serious Systemic Infections, Necrotizing Enterocolitis
Interventions
Metronidazole
Drug
Lead sponsor
Michael Cohen-Wolkowiez
Other
Eligibility
Up to 90 Days
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
3
States / cities
Orange, California • Wichita, Kansas • Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Feb 5, 2014 · Synced Sep 19, 2026, 2:15 AM EDT
Completed No phase listed Observational

Observational Study of Surgical Treatment of Necrotizing Enterocolotis

NCT01223261
View directory record Official record
Conditions
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Enterocolitis, Necrotizing, Intestinal Perforation
Interventions
Not listed
Lead sponsor
NICHD Neonatal Research Network
Network
Eligibility
Up to 6 Weeks
Enrollment
156 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2004
U.S. locations
17
States / cities
Birmingham, Alabama • Palo Alto, California • San Diego, California + 13 more
Source: ClinicalTrials.gov public record
Updated Mar 21, 2019 · Synced Sep 19, 2026, 2:15 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Alteration of Stool Microbiota in Preterm Infants With Anemia

NCT03554278
View directory record Official record
Conditions
Anemia, Neonatal, Necrotizing Enterocolitis, Dysbiosis
Interventions
Not listed
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
7 Days to 30 Days
Enrollment
57 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2023
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Feb 4, 2025 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Phase 4 Interventional

NICU Antibiotics and Outcomes Trial

NCT03997266
View directory record Official record
Conditions
Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Death; Neonatal
Interventions
Ampicillin, Gentamycin, Normal saline
Drug
Lead sponsor
Michael Morowitz
Other
Eligibility
Up to 4 Hours
Enrollment
359 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
14
States / cities
Mobile, Alabama • San Diego, California • New Haven, Connecticut + 10 more
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Not applicable Interventional

Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants

NCT00005888
View directory record Official record
Conditions
Necrotizing Enterocolitis, Sepsis
Interventions
Fortified Pasteurized Donor Human Milk supplement, Preterm Formula supplement
Behavioral
Lead sponsor
National Center for Research Resources (NCRR)
NIH
Eligibility
0 Years to 96 Hours
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1997
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 23, 2005 · Synced Sep 19, 2026, 2:15 AM EDT
Terminated No phase listed Observational

Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants

NCT01062828
View directory record Official record
Conditions
Premature Newborn, Necrotizing Enterocolitis
Interventions
Citrulline samples
Diagnostic Test
Lead sponsor
University of Miami
Other
Eligibility
Not listed
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2017
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Aug 27, 2017 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Not applicable Interventional

Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)

NCT02116699
View directory record Official record
Conditions
Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
Interventions
oropharyngeal mother's milk, oropharyngeal sterile water
Other
Lead sponsor
Endeavor Health
Other
Eligibility
1 Day to 4 Days
Enrollment
260 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2022
U.S. locations
5
States / cities
Miami, Florida • Evanston, Illinois • Park Ridge, Illinois + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 28, 2023 · Synced Sep 19, 2026, 2:15 AM EDT
Terminated Not applicable Interventional

Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

NCT01062815
View directory record Official record
Conditions
Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia, Necrotizing Enterocolitis
Interventions
Parenteral Nutrition
Dietary Supplement
Lead sponsor
University of Miami
Other
Eligibility
Up to 7 Days
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 22, 2015 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Not applicable Interventional Results available

Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

NCT01029353
View directory record Official record
Conditions
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Enterocolitis, Necrotizing, Intestinal Perforation
Interventions
Laparotomy, Drainage
Procedure
Lead sponsor
NICHD Neonatal Research Network
Network
Eligibility
Up to 8 Weeks
Enrollment
529 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2019
U.S. locations
22
States / cities
Birmingham, Alabama • Los Angeles, California • Palo Alto, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2024 · Synced Sep 19, 2026, 2:15 AM EDT
Completed No phase listed Observational

Probiotics/TPN in the NICU

NCT04977817
View directory record Official record
Conditions
Total Parenteral Nutrition, Necrotizing Enterocolitis of Newborn
Interventions
Similac Probiotic Tri-Blend
Dietary Supplement
Lead sponsor
Pediatrix
Other
Eligibility
Not listed
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
2
States / cities
Mesa, Arizona • Phoenix, Arizona
Source: ClinicalTrials.gov public record
Updated Aug 28, 2022 · Synced Sep 19, 2026, 2:15 AM EDT
Not listed No phase listed Observational

Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy

NCT01855347
View directory record Official record
Conditions
Infant, Premature, Diseases, Hypoxia, Necrotizing Enterocolitis
Interventions
Near Infrared Spectroscopy
Device
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
Up to 3 Weeks
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 24, 2015 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Phase 1 Interventional Results available

STP206 for the Prevention of Necrotizing Enterocolitis (NEC)

NCT01954017
View directory record Official record
Conditions
Necrotizing Enterocolitis
Interventions
STP206, Control
Biological · Other
Lead sponsor
Leadiant Biosciences, Inc.
Industry
Eligibility
1 Day to 4 Days
Enrollment
103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
13
States / cities
Hartford, Connecticut • Sunrise, Florida • Augusta, Georgia + 10 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2020 · Synced Sep 19, 2026, 2:15 AM EDT
Not listed Phase 1Phase 2 Interventional

Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO

NCT02851472
View directory record Official record
Conditions
Anemia
Interventions
Inhaled Nitric Oxide, Placebo
Drug
Lead sponsor
New York Medical College
Other
Eligibility
2 Weeks and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
4
States / cities
Springfield, Massachusetts • Stony Brook, New York • Valhalla, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 23, 2019 · Synced Sep 19, 2026, 2:15 AM EDT
Active, not recruiting No phase listed Observational Accepts healthy volunteers

Early Predictors of Necrotizing Enterocolitis in Neonates

NCT03210831
View directory record Official record
Conditions
Necrotizing Enterocolitis
Interventions
Not listed
Lead sponsor
Nationwide Children's Hospital
Other
Eligibility
Up to 7 Days
Enrollment
450 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2026
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Jun 7, 2026 · Synced Sep 19, 2026, 2:15 AM EDT
Not listed Phase 2Phase 3 Interventional

Cysteine Supplementation in Critically Ill Neonates

NCT00254176
View directory record Official record
Conditions
Sepsis, Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Retinopathy of Prematurity, Systemic Inflammatory Response Syndrome
Interventions
Parenteral cysteine-HCl supplementation, Placebo - added premasol
Dietary Supplement
Lead sponsor
University of California, Los Angeles
Other
Eligibility
Up to 30 Days
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2011
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Feb 25, 2010 · Synced Sep 19, 2026, 2:15 AM EDT
Terminated Phase 3 Interventional Results available

CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis

NCT03549507
View directory record Official record
Conditions
Necrotizing Enterocolitis of Newborn, Bowel Ischemic
Interventions
Sulfur hexafluoride lipid-type A microspheres
Drug
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
0 Years to 18 Months
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Nov 11, 2024 · Synced Sep 19, 2026, 2:15 AM EDT
Active, not recruiting No phase listed Observational

A Cohort Study of the Intestinal Microbiota of Premature Infants

NCT03717584
View directory record Official record
Conditions
Necrotizing Enterocolitis, Bronchopulmonary Dysplasia, Growth Failure
Interventions
Not listed
Lead sponsor
University of California, Davis
Other
Eligibility
Up to 33 Weeks
Enrollment
300 participants
Timeline
2018 – 2027
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Apr 2, 2026 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Phase 2 Interventional

Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus

NCT00187447
View directory record Official record
Conditions
Patent Ductus Arteriosus
Interventions
indomethacin (two different dosing regimens)
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
Up to 48 Hours
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2006
U.S. locations
3
States / cities
Davis, California • Chicago, Illinois • Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Jun 3, 2008 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome

NCT02477423
View directory record Official record
Conditions
Premature Birth of Newborn, Enterocolitis, Necrotizing
Interventions
Ampicillin, Gentamicins, Placebo
Drug
Lead sponsor
University of Chicago
Other
Eligibility
Up to 6 Hours
Enrollment
27 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2019
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Oct 7, 2020 · Synced Sep 19, 2026, 2:15 AM EDT
Recruiting No phase listed Observational

Study of Normal Intestinal Development and Disease in Premature and Term Neonates

NCT06681129
View directory record Official record
Conditions
NEC, Necrotizing Enterocolitis, Intestinal Disease, Human Development
Interventions
Not listed
Lead sponsor
Boston Children's Hospital
Other
Eligibility
Up to 2 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2034
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 26, 2026 · Synced Sep 19, 2026, 2:15 AM EDT
Terminated No phase listed Observational

Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates

NCT01735552
View directory record Official record
Conditions
Anemia of Prematurity, Necrotizing Enterocolitis
Interventions
Not listed
Lead sponsor
University of Utah
Other
Eligibility
Up to 12 Weeks
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
3
States / cities
Murray, Utah • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated May 4, 2015 · Synced Sep 19, 2026, 2:15 AM EDT
Terminated Not applicable Interventional Accepts healthy volunteers

Impact of Feeding on Pro-Inflammatory Cytokine Response in Neonates Receiving a RBC Transfusion

NCT01949896
View directory record Official record
Conditions
Transfusions
Interventions
NPO, Control group: continue feedings
Other
Lead sponsor
Christiana Care Health Services
Other
Eligibility
3 Days to 6 Months
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2016
U.S. locations
1
States / cities
Newark, Delaware
Source: ClinicalTrials.gov public record
Updated Mar 10, 2016 · Synced Sep 19, 2026, 2:15 AM EDT
Completed Phase 1 Interventional

Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

NCT00840983
View directory record Official record
Conditions
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis, Motor Skills Disorders
Interventions
delayed cord clamping
Procedure
Lead sponsor
University of Rhode Island
Other
Eligibility
Female only
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2006
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Nov 29, 2015 · Synced Sep 19, 2026, 2:15 AM EDT
Terminated Not applicable Interventional Results available

NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

NCT03963011
View directory record Official record
Conditions
Enterocolitis, Necrotizing, Premature Infant
Interventions
Bowel Ultrasound
Diagnostic Test
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
Up to 28 Weeks
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated Jan 9, 2022 · Synced Sep 19, 2026, 2:15 AM EDT