13 completed. 13 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 13 |
| Phase 2 | 1 | Completed 1 |
Follow Neonatal Sepsis: new trials by email Literature Review of Neonatal Sepsis trials Research Report on Neonatal Sepsis
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 |
|---|---|---|---|---|---|---|
| Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age Ceftobiprole medocaril - Neonatal Sepsis | Phase 3 | Completed | Basilea Pharmaceutica | 9 | 2023-08-06 | 2025-07-28 |
| Use of Probiotics to Reduce Infections, Death and ESBL Colonisation Labinic (R) probiotic mixture, Placebo - Neonatal Sepsis | Phase 3 | Completed | Haydom Lutheran Hospital | 2000 | 2022-02-01 | 2025-04-25 |
| Azithromycin-Prevention in Labor Use Study (A-PLUS) Azithromycin, Placebo - Maternal Death, Maternal Infections Affecting Fetus or Newborn | Phase 3 | Completed | NICHD Global Network for Women's and Children's Health | 58747 | 2020-09-01 | 2024-10-24 |
| Pentoxifylline Dose Optimization in Neonatal Sepsis Pentoxifylline - Neonatal Late Onset Sepsis | Phase 3 | Completed | Erasmus Medical Center | 30 | 2020-01-12 | 2024-08-09 |
| 7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis 7-day course of antibiotics, 14-day course of antibiotics - Infant, Newborn, Neonatal SEPSIS | Phase 3 | Completed | Indian Council of Medical Research | 261 | 2019-01-01 | 2023-11-02 |
| Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death Azithromycin, Placebo Oral Tablet - Neonatal SEPSIS | Phase 3 | Completed | London School of Hygiene and Tropical Medicine | 11985 | 2017-10-21 | 2022-03-31 |
| Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis IVIG - Neonatal Sepsis | Phase 3 | Completed | Hormozgan University of Medical Sciences | 92 | 2015-11-01 | 2016-11-04 |
| Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis Meropenem. - Late Onset Neonatal Sepsis | Phase 3 | Completed | Mansoura University | 100 | 2013-08-01 | 2015-07-21 |
| Lactoferrin for Prevention of Sepsis in Infants Bovine Lactoferrin, Maltodextrin - Late Onset Neonatal Sepsis | Phase 3 | Completed | Universidad Peruana Cayetano Heredia | 414 | 2012-05-01 | 2021-12-06 |
| Pentoxifylline and Late Onset Sepsis in Preterm Infants Pentoxifylline (PTX), Placebo - Neonatal Late Onset Sepsis | Phase 3 | Completed | Abd Elazeez Attala Shabaan | 120 | 2011-05-01 | 2014-06-16 |
| Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal Sunflower seed oil, Mustard seed oil - Neonatal Mortality, Neonatal Sepsis | Phase 3 | Completed | Johns Hopkins Bloomberg School of Public Health | 29260 | 2010-11-01 | 2018-04-23 |
| Simplified Antibiotic Therapy for Sepsis in Young Infants procaine penicillin and gentamicin, amoxicillin and gentamicin, procaine penicillin, gentamicin, amoxicillin - Neonatal Sepsis, Sepsis | Phase 3 | Completed | Aga Khan University | 2543 | 2009-12-01 | 2015-06-29 |
| Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term Ampicillin + gentamicin - Chorioamnionitis, Puerperal Endometritis | Phase 2 / Phase 3 | Completed | Hospital de Santa Maria, Portugal | 161 | 2008-10-01 | 2016-11-28 |
Infections (2) · Sepsis (2) · COVID-19 (1) · Chorioamnionitis (1) · Endometritis (1) · Fetal Membranes, Premature Rupture (1) · Maternal Death (1) · Perinatal Death (1) · Pregnancy Complications, Infectious (1) · Puerperal Infection (1) · Recurrence (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (13) · Infant, Newborn, Diseases (13) · Inflammation (13) · Pathologic Processes (13) · Pathological Conditions, Signs and Symptoms (13) · Systemic Inflammatory Response Syndrome (13) · Infections (11) · Sepsis (11) · Female Urogenital Diseases and Pregnancy Complications (2) · Pregnancy Complications (2) · Urogenital Diseases (2) · Adnexal Diseases (1) · Coronaviridae Infections (1) · Coronavirus Infections (1) · Death (1)
Azithromycin (2) · Gentamicins (2) · Pentoxifylline (2) · Amoxicillin (1) · Ampicillin (1) · Immunoglobulins, Intravenous (1) · Lactoferrin (1) · Meropenem (1) · Penicillin G Procaine (1) · Sunflower Oil (1) · ceftobiprole medocaril (1) · maltodextrin (1)
Abd Elazeez Attala Shabaan (1) · Aga Khan University (1) · Basilea Pharmaceutica (1) · Erasmus Medical Center (1) · Haydom Lutheran Hospital (1) · Hormozgan University of Medical Sciences (1) · Hospital de Santa Maria, Portugal (1) · Indian Council of Medical Research (1) · Johns Hopkins Bloomberg School of Public Health (1) · London School of Hygiene and Tropical Medicine (1) · Mansoura University (1) · NICHD Global Network for Women's and Children's Health (1) · Universidad Peruana Cayetano Heredia (1)
India (2) · Pakistan (2) · Poland (2) · Bangladesh (1) · Bulgaria (1) · Burkina Faso (1) · Democratic Republic of the Congo (1) · Egypt (1) · Estonia (1) · Germany (1) · Guatemala (1) · Iran (1) · Kenya (1) · Latvia (1) · Lithuania (1)
Abd Elazeez AT Shabaan, PhD (1) · Anna Roca, PhD (1) · Filipa Faria Vaz Passos, Dr (1) · Luke C Mullany, PhD (1) · Marc Engelhardt, MD (1) · Marion Koso-Thomas, MD (1) · Nina Langeland, MD, PhD (1) · Shiyam S Sunder, MBBS (1) · Sinno Simons, MD, PhD (1) · Sourabh Dutta (1) · Theresa J Ochoa, MD (1)
PMID 23090521, PMID 23945571, PMID 25970116, PMID 27918382, PMID 27988146, PMID 28125095, PMID 28428183, PMID 29297386, PMID 29613975, PMID 29859084, PMID 30611255, PMID 30743197, PMID 31870338, PMID 32037149, PMID 32393349, PMID 32401307, PMID 32404437, PMID 32819989, PMID 33926519, PMID 34794420, PMID 35589346, PMID 35986258, PMID 36403158, PMID 36456014, PMID 36757318, PMID 36881034, PMID 37648383, PMID 37709319, PMID 38423547, PMID 38752311, PMID 38853894, PMID 38958728, PMID 39252007, PMID 40155105, PMID 40155106, PMID 40280737, PMID 40412397, PMID 41527950, PMID 41535953, PMID 41806992, PMID 42133947, PMID 42736543, PMID 42754858, PMID 42829441
R01HD067694 (1), U24HD092094 (1)