9 completed, 4 unknown, 2 active not recruiting, 1 not yet recruiting. 17 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 9, Unknown 4, Active not recruiting 2, Not yet recruiting 1, Terminated 1 |
| Phase 2 | 3 | Active not recruiting 1, Completed 1, Unknown 1 |
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 |
|---|---|---|---|---|---|---|
| Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants Multi-strain probiotics - Necrotizing Enterocolitis (NEC) | Phase 3 | Not yet recruiting | University of Calgary | 2170 | 2025-06-01 | 2025-02-05 |
| Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis Pentoxifylline, Probiotic Formula - Necrotizing Enterocolitis | Phase 3 | Completed | Tanta University | 75 | 2022-06-30 | 2024-05-20 |
| Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion Continuous amnioinfusion with Amnion Flush Solution through the intraamniotic catheter - Bronchopulmonary Dysplasia, Necrotizing Enterocolitis | Phase 3 | Unknown | Martin-Luther-Universität Halle-Wittenberg | 68 | 2021-01-01 | 2021-01-12 |
| IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study IBP-9414, Placebo - Necrotizing Enterocolitis | Phase 3 | Active not recruiting | Infant Bacterial Therapeutics | 2158 | 2019-07-04 | 2024-04-12 |
| 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 |
| Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies. bLF (Bovine lactoferrin), Glucon-D 99.4% (Placebo) - Neonatal Sepsis, Necrotizing Enterocolitis | Phase 3 | Unknown | Aga Khan University | 300 | 2018-05-01 | 2020-04-09 |
| The Efficacy of Symbiotic on Cytokines distilled water, symbiotic - Necrotising Enterocolitis | Phase 3 | Completed | Zeynep Kamil Maternity and Pediatric Research and Training Hospital | 70 | 2013-07-01 | 2014-08-08 |
| Role of Probiotics for Prevention of NEC in Preterm VLBW Infants Probiotics, Breast milk - Necrotizing Enterocolitis | Phase 3 | Completed | Sylhet M.A.G.Osmani Medical College | 60 | 2012-07-01 | 2016-01-08 |
| Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants Lactobacillus reuteri, Placebo - Necrotizing Enterocolitis, Very Low Birth Weight Infants | Phase 3 | Completed | Zekai Tahir Burak Women's Health Research and Education Hospital | 400 | 2012-02-01 | 2013-05-13 |
| Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants Probiotic, Placebo - Necrotizing Enterocolitis | Phase 3 | Completed | University of Stellenbosch | 184 | 2011-07-01 | 2013-07-22 |
| 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 |
| Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants Saccharomyces boulardii, Placebo - Necrotizing Enterocolitis, Very Low Birth Weight Infants | Phase 3 | Unknown | Zekai Tahir Burak Women's Health Research and Education Hospital | 220 | 2011-02-01 | 2011-08-08 |
| Prophylactic Probiotics in Premature Infants Lactobacillus reuteri, Placebo - Death, Nosocomial Infection | Phase 3 | Terminated | Colombian Neonatal Research Network | 751 | 2008-08-01 | 2011-06-22 |
| Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis Vitamin A - Sepsis, Necrotizing Enterocolitis | Phase 3 | Completed | Johns Hopkins University | 424 | 2006-12-01 | 2013-09-25 |
| 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 |
| Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants probiotics - Nosocomial Infection, Necrotizing Enterocolitis | Phase 3 | Completed | King Chulalongkorn Memorial Hospital | 160 | 2005-01-01 | 2011-04-22 |
| Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) indomethacin, Indomethacin, Placebo - Infant, Very Low Birth Weight, Infant, Premature | Phase 3 | Completed | NICHD Neonatal Research Network | 1202 | 1993-11-01 | 2015-06-08 |
Sepsis (4) · Bronchopulmonary Dysplasia (2) · Cross Infection (2) · Premature Birth (2) · Acquired Immunodeficiency Syndrome (1) · Death (1) · Ductus Arteriosus, Patent (1) · Intracranial Hemorrhages (1) · Meningitis (1) · Neonatal Sepsis (1) · Pneumonia (1) · Preterm Premature Rupture of the Membranes (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 (8) · Pathologic Processes (8) · Pathological Conditions, Signs and Symptoms (8) · Inflammation (5) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (4) · Systemic Inflammatory Response Syndrome (4) · Infant, Newborn, Diseases (3) · Lung Diseases (3) · Respiratory Tract Diseases (3) · Cardiovascular Diseases (2)
Probiotics (3) · Arginine (1) · Glutamine (1) · Indomethacin (1) · Milk, Human (1) · Pentoxifylline (1) · Vitamin A (1) · amino-acid, glucose, and electrolyte solution (1)
Zekai Tahir Burak Women's Health Research and Education Hospital (2) · Aga Khan University (1) · Ain Shams University (1) · Colombian Neonatal Research Network (1) · Infant Bacterial Therapeutics (1) · Johns Hopkins University (1) · King Chulalongkorn Memorial Hospital (1) · Martin-Luther-Universität Halle-Wittenberg (1) · NICHD Neonatal Research Network (1) · Sylhet M.A.G.Osmani Medical College (1) · Tanta University (1) · Thomas Abrahamsson, MD, PhD (1) · University of Calgary (1) · University of California, Los Angeles (1) · University of Stellenbosch (1)
Turkey (Türkiye) (3) · United States (3) · Egypt (2) · Bangladesh (1) · Bulgaria (1) · Canada (1) · Colombia (1) · France (1) · Germany (1) · Hungary (1) · Israel (1) · Pakistan (1) · Poland (1) · Romania (1) · Serbia (1)
Almas Aamir, MSC (1) · Avroy A. Fanaroff, MD (1) · Barbara J. Stoll, MD (1) · Barbara Schmidt, MD (1) · Charles R. Bauer, MD (1) · Christian L Coles, PhD (1) · David K. Stevenson, MD (1) · Evette van Niekerk, M Dietetics (1) · Fahri Ovali (1) · GHada A. Saleh, MRCPCH (1) · Gamze Demirel, MD (1) · Jon E. Tyson, MD MPH (1) · Josef Neu, MD (1) · Juan M Lozano, MD, Msc (1) · Lu-Ann Papile, MD (1)
PMID 11430325, PMID 12622582, PMID 16647401, PMID 16769377, PMID 17188612, PMID 17307535, PMID 17636753, PMID 18245398, PMID 19117897, PMID 21727276, PMID 23071204, PMID 24309022, PMID 24919691, PMID 25861285, PMID 28710882, PMID 33006765, PMID 33058137, PMID 33704071, PMID 34815288, PMID 36143388, PMID 37493095, PMID 38545091, PMID 38556499, PMID 40348496
K01DK075478 (1), K08HD052885 (1), M01RR000070 (1), M01RR000997 (1), U10HD021364 (1), U10HD021373 (1), U10HD021385 (1), U10HD021397 (1), U10HD027851 (1), U10HD027880 (1), U10HD027881 (1), U10HD027904 (1), U10HD034216 (1)