8 completed, 5 unknown, 2 active not recruiting, 1 recruiting. 17 Phase 2, 5 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 17 | Completed 8, Unknown 5, Active not recruiting 2, Recruiting 1, Withdrawn 1 |
| Phase 1 | 5 | Completed 4, Recruiting 1 |
| Phase 3 | 2 | Active not recruiting 1, Unknown 1 |
Follow Necrotizing Enterocolitis: new trials by email Literature Review of Necrotizing Enterocolitis trials Research Report on Necrotizing Enterocolitis
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 |
| 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 |
| 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 |
| 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 | |
| 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 |
| 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 |
| Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial recombinant human G-CSF, and rhEPO, rh G-CSF, rh EPO - Feeding Intolerance, Necrotizing Enterocolitis | Phase 1 / Phase 2 | Completed | Ain Shams University | 93 | 2010-01-01 | 2011-09-27 |
| Prebiotics in the Prevention of Necrotizing Enterocolitis Galacto-oligosaccharide (GOS), Placebo - Necrotizing Enterocolitis | Phase 2 | Unknown | Shaare Zedek Medical Center | 260 | 2009-07-01 | 2014-01-03 |
| Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections meropenem - Necrotizing Enterocolitis, Intra-abdominal Infection | Phase 1 / Phase 2 | Completed | The Emmes Company, LLC | 200 | 2008-06-01 | 2023-04-25 |
| Cysteine Supplementation in Critically Ill Neonates Parenteral cysteine-HCl supplementation, Placebo - added premasol - Sepsis, Bronchopulmonary Dysplasia | Phase 2 / Phase 3 | Unknown | University of California, Los Angeles | 108 | 2006-09-01 | 2010-02-26 |
| Lactulose Supplementation in Premature Infants Lactulose, Dextrose - Necrotizing Enterocolitis, Sepsis | Phase 2 | Completed | Bnai Zion Medical Center | 28 | 2005-02-01 | 2008-02-15 |
| Pentoxifylline in the Treatment of NEC in Premature Neonates Pentoxifylline - Necrotizing Enterocolitis | Phase 2 | Unknown | Shaare Zedek Medical Center | 50 | 2005-01-01 | 2008-05-23 |
Enterocolitis, Necrotizing (17) · Sepsis (5) · Premature Birth (4) · Asthma (1) · Body Weight (1) · Bronchopulmonary Dysplasia (1) · Disease (1) · Ductus Arteriosus, Patent (1) · Failure to Thrive (1) · Intestinal Perforation (1) · Intraabdominal Infections (1) · Retinopathy of Prematurity (1) · Systemic Inflammatory Response Syndrome (1)
Digestive System Diseases (17) · Enterocolitis (17) · Gastroenteritis (17) · Gastrointestinal Diseases (17) · Intestinal Diseases (17) · Infections (6) · Inflammation (5) · Pathologic Processes (5) · Pathological Conditions, Signs and Symptoms (5) · Female Urogenital Diseases and Pregnancy Complications (4) · Obstetric Labor Complications (4) · Obstetric Labor, Premature (4) · Pregnancy Complications (4) · Systemic Inflammatory Response Syndrome (4) · Urogenital Diseases (4)
4'-galactooligosaccharide (1) · Anti-Inflammatory Agents, Non-Steroidal (1) · Docosahexaenoic Acids (1) · Fatty Acids, Omega-3 (1) · Glucose (1) · Lactulose (1) · Melatonin (1) · Meropenem (1) · Milk, Human (1) · Pentoxifylline (1) · Standard of Care (1) · Sunflower Oil (1) · amino-acid, glucose, and electrolyte solution (1)
Shaare Zedek Medical Center (3) · Ain Shams University (1) · Bnai Zion Medical Center (1) · Children's Hospital and Institute of Child Health, Multan (1) · Coordinación de Investigación en Salud, Mexico (1) · Ilocos Training and Regional Medical Center (1) · Infant Bacterial Therapeutics (1) · Loma Linda University (1) · Noveome Biotherapeutics, formerly Stemnion (1) · Ostergotland County Council, Sweden (1) · The Emmes Company, LLC (1) · The Hospital for Sick Children (1) · Thomas Abrahamsson, MD, PhD (1) · University of California, Los Angeles (1) · University of California, San Francisco (1)
United States (7) · Israel (4) · Sweden (3) · Canada (1) · Mexico (1) · Philippines (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Cathy Hammerman, MD (3) · Agostino Pierro, OBE, MD (1) · Arieh Riskin, MD (1) · Daisy Evangeline C Garcia, MD (1) · Danny Benjamin, MD, PhD, MPH (1) · Gerald Gollin, MD (1) · Josef Neu, MD (1) · Mariela Bernabe-Garcia, PhD (1) · Navid P Roodaki, MD (1) · Ron Shaoul, MD (1) · Ronald Clyman, MD (1) · Stephen B Shew, M.D. (1) · Thomas Abrahamsson, MD, PhD (1) · Thomas R Abrahamsson, MD, PhD (1)
PMID 22955430, PMID 25155966, PMID 30340932, PMID 30850756, PMID 31255386, PMID 33006765, PMID 33671220, PMID 33763652, PMID 33923278, PMID 34815288, PMID 38545091
K08HD052885 (1)