14 completed, 7 unknown, 3 terminated, 2 active not recruiting. 28 Phase 2, 8 Phase 1, 3 Phase 3.
Follow Enterocolitis, Necrotizing: new trials by email Literature Review of Enterocolitis, Necrotizing trials Research Report on Enterocolitis, Necrotizing
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC) ST266 - Necrotizing Enterocolitis | Phase 1 / Phase 2 | Recruiting | Noveome Biotherapeutics, formerly Stemnion | 36 | 2024-08-19 | 2026-04-13 |
| RIC-NEC Randomized Controlled Trial Remote ischemic conditioning (RIC) + Standard of Care for NEC, Standard of Care for NEC - Necrotizing Enterocolitis | Phase 2 | Completed | The Hospital for Sick Children | 86 | 2023-02-09 | 2026-11-03 |
| Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis Melatonin 6 MG, Breast Milk - Necrotizing Enterocolitis | Phase 1 / Phase 2 | Completed | Ilocos Training and Regional Medical Center | 100 | 2021-03-01 | 2024-06-20 |
| The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Lactobacillus Reuteri DSM 17938, Placebo - Necrotizing Enterocolitis, Sepsis | Phase 2 | Unknown | Children's Hospital and Institute of Child Health, Multan | 120 | 2020-10-01 | 2020-09-09 |
| Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO Inhaled Nitric Oxide, Placebo - Anemia | Phase 1 / Phase 2 | Unknown | New York Medical College | 50 | 2019-02-06 | 2019-04-24 |
| Human Milk Fortification in Extremely Preterm Infants H2MF, Bovine milk-based fortifier - Necrotizing Enterocolitis, Sepsis | Phase 2 / Phase 3 | Active not recruiting | Thomas Abrahamsson, MD, PhD | 229 | 2019-02-01 | 2024-07-23 |
| Antibiotic "Dysbiosis" in Preterm Infants Antibiotic, Gastric fluid, Breast milk - Enterocolitis, Necrotizing, Bacteremia | Phase 2 | Completed | University of Florida | 98 | 2017-01-16 | 2024-06-05 |
| Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis Heat Inactivated probiotics, Placebo - Necrotizing Enterocolitis, Enterocolitis, Necrotizing | Phase 2 | Unknown | Shaare Zedek Medical Center | 450 | 2016-06-01 | 2016-06-16 |
| IBP-9414 for the Prevention of Necrotizing Enterocolitis IBP-9414, Placebo - Necrotizing Enterocolitis | Phase 2 | Completed | Infant Bacterial Therapeutics | 120 | 2016-05-27 | 2017-12-29 |
| SMOFlipid to Lessen the Severity of Neonatal Cholestasis SMOFlipid - Cholestasis, Jaundice, Obstructive | Phase 1 / Phase 2 | Terminated | University of Florida | 2 | 2016-05-01 | 2017-04-17 |
| Prediction of NEC With Urinary iFABP Assessment of urinary iFABP, Administration of enteral feedings - Prematurity, Necrotizing Enterocolitis | Phase 2 | Withdrawn | Loma Linda University | 2014-11-01 | 2015-05-14 | |
| Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis EPO, Normal saline - Premature Infant | Phase 2 | Completed | Zhengzhou University | 1285 | 2014-01-01 | 2019-04-19 |
| Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus pharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID - Patent Ductus Arteriosus, Surgery | Phase 2 | Completed | University of California, San Francisco | 202 | 2013-12-01 | 2018-11-30 |
| Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies Microlipid with fish oil, Microlipid - Prematurity, Intestine Perforation | Phase 2 | Completed | Wake Forest University | 18 | 2012-10-01 | 2018-12-04 |
| Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Docosahexaenoic acid (DHA), Placebo - Necrotizing Enterocolitis | Phase 1 / Phase 2 | Completed | Coordinación de Investigación en Salud, Mexico | 225 | 2012-10-01 | 2021-03-24 |
| Prophylactic Probiotics to Extremely Low Birth Weight Prematures Lactobacillus reuteri, Placebo - Feeding; Difficult, Newborn, Growth Failure | Phase 2 | Active not recruiting | Ostergotland County Council, Sweden | 134 | 2012-06-01 | 2026-11-13 |
| Safety and Dosing Study of Glucagon-like Peptide 2 (GLP-2) in Infants and Children With Intestinal Failure Glucagon-Like Peptide 2, Glucagon like peptide-2 - Intestinal Failure, Short Bowel Syndrome | Phase 1 / Phase 2 | Terminated | Alberta Children's Hospital | 13 | 2012-01-01 | 2014-12-23 |
| Effect of L-arginine and Glutamine on Preterm Glutamine, l-arginine - NEC, Sepsis | Phase 2 / Phase 3 | Completed | Ain Shams University | 75 | 2011-05-01 | 2014-04-15 |
| Lactated Ringer's Solution in Neonates With Feeding Intolerance Lactated Ringer's Solution - Intestinal Disease, Feeding Disorder Neonatal | Phase 2 | Unknown | McGill University Health Centre/Research Institute of the McGill University Health Centre | 60 | 2010-11-01 | 2011-08-04 |
| Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics probiotics Lactobacillus acidophilus boucardii - Infectious Diseases | Phase 2 | Completed | Coordinación de Investigación en Salud, Mexico | 150 | 2010-03-01 | 2014-08-27 |
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Premature Birth (9) · Sepsis (6) · Bronchopulmonary Dysplasia (2) · Ductus Arteriosus, Patent (2) · Intestinal Perforation (2) · Short Bowel Syndrome (2) · Anemia (1) · Asthma (1) · Bacteremia (1) · Body Weight (1) · Cholestasis (1) · Communicable Diseases (1) · Disease (1) · Failure to Thrive (1)
Digestive System Diseases (28) · Enterocolitis (28) · Gastroenteritis (28) · Gastrointestinal Diseases (28) · Intestinal Diseases (27) · Pathologic Processes (11) · Pathological Conditions, Signs and Symptoms (11) · Female Urogenital Diseases and Pregnancy Complications (9) · Infections (9) · Obstetric Labor Complications (9) · Obstetric Labor, Premature (9) · Pregnancy Complications (9) · Urogenital Diseases (9) · Inflammation (7) · Systemic Inflammatory Response Syndrome (6)
Milk, Human (2) · 4'-galactooligosaccharide (1) · Ampicillin (1) · Anti-Bacterial Agents (1) · Anti-Inflammatory Agents, Non-Steroidal (1) · Arginine (1) · Biological Evolution (1) · Cefotaxime (1) · Docosahexaenoic Acids (1) · Drainage (1) · Fatty Acids, Omega-3 (1) · Fish Oils (1) · Gentamicins (1) · Glucagon-Like Peptide 2 (1) · Glucose (1)
Shaare Zedek Medical Center (3) · Ain Shams University (2) · Coordinación de Investigación en Salud, Mexico (2) · University of California, San Francisco (2) · University of Florida (2) · Alberta Children's Hospital (1) · Bnai Zion Medical Center (1) · Children's Hospital and Institute of Child Health, Multan (1) · China Medical University Hospital (1) · Ilocos Training and Regional Medical Center (1) · Infant Bacterial Therapeutics (1) · Loma Linda University (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · New York Medical College (1) · Noveome Biotherapeutics, formerly Stemnion (1)
United States (12) · Israel (4) · Canada (3) · Sweden (3) · Mexico (2) · China (1) · Egypt (1) · Philippines (1) · Taiwan (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Cathy Hammerman, MD (3) · Josef Neu, MD (3) · Agostino Pierro, OBE, MD (1) · Arieh Riskin, MD (1) · Changlian Zhu, PhD (1) · Daisy Evangeline C Garcia, MD (1) · Danny Benjamin, MD, PhD, MPH (1) · David Sigalet, MD PhD (1) · Edmund LaGamma, MD (1) · GHada A. Saleh, MRCPCH (1) · Gaelle Sadani, MD (1) · Gerald Gollin, MD (1) · Louis Beaumier, MD (1)
PMID 17636753, PMID 18829790, PMID 20980771, PMID 22818551, PMID 22955430, PMID 23453547, PMID 25104129, PMID 25155966, PMID 25861285, PMID 25927273, PMID 26340878, PMID 29906796, PMID 30340932, PMID 30850756, PMID 31255386, PMID 32771013, PMID 33006765, PMID 33076939, PMID 33479274, PMID 33671220, PMID 33763652, PMID 33923278, PMID 34815288, PMID 37308133, PMID 38545091, PMID 39373498
K08HD052885 (1), R21HD088005 (1)