101 completed, 48 unknown, 16 recruiting, 11 not yet recruiting. 53 Not applicable, 24 Phase 3, 16 Phase 4, 10 Phase 2, 4 Phase 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 |
|---|---|---|---|---|---|---|
| G-CSF In Neonatal Sepsis With Neutropenia Granulocyte-colony stimulating factor (G-CSF), Standard Sepsis Management - Neonatal Sepsis, Neutropenia | Not applicable | Not yet recruiting | University of Health Sciences Lahore | 52 | 2027-02-15 | 2026-10-22 |
| Cahnge in Management of Suspected Early Onset Neonetal Sepsis After Assimilation of Early Onset Sepsis Calculator No intervention - Neonatal Early-onset Sepsis | Not yet recruiting | Hillel Yaffe Medical Center | 6300 | 2026-12-01 | 2026-04-07 | |
| Neonatal Catheter Lock for Infection Prevention Taurolidine 2% lock, Normal saline lock - CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection | Not applicable | Not yet recruiting | University of Turin, Italy | 576 | 2026-10-01 | 2026-05-13 |
| T6A Biomarker for Detection of Bacterial Infection in Newborn Infants Sepsis, Newborn Sepsis | Recruiting | Salzburger Landeskliniken | 210 | 2026-09-03 | 2026-09-09 | |
| CBC Indices and Serum Lactate in Neonatal Sepsis Neonatal Sepsis, Sepsis | Not yet recruiting | Assiut University | 80 | 2026-08-01 | 2026-07-10 | |
| MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates MDW measurement - Late Onset Neonatal Sepsis | Recruiting | Tanta University | 60 | 2026-07-01 | 2026-09-15 | |
| PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes Ampicillin, Ampicillin + gentamicin - Rupture of Membranes Prior to Onset of Labor | Phase 4 | Not yet recruiting | Sarawak General Hospital | 320 | 2026-07-01 | 2026-05-04 |
| Wireless MicroPremVitals Button Sensor in the NICU Wireless MicroPremVitals Button Sensor System - Premature Birth, Fragility | Not applicable | Recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | 10 | 2026-06-19 | 2026-07-28 |
| Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis cardiac troponin, and blood culture - Neonatal Sepsis, Markers | Not yet recruiting | Assiut University | 80 | 2026-05-01 | 2026-05-07 | |
| Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI Renal Angina Index (RAI) - Acute Kidney Injury, Acute Kidney Injury Due to Sepsis | Not applicable | Withdrawn | Children's Hospital Medical Center, Cincinnati | 2026-03-01 | 2026-03-24 | |
| Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal Sepsis N-Acetyl Cysteine (NAC), Normal Saline - Neonatal Sepsis | Phase 3 | Not yet recruiting | Ain Shams University | 50 | 2026-02-01 | 2026-02-02 |
| The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates POP-Score Assessment, Near-Infrared Spectroscopy (NIRS) - Prematurity, Infections, NIRS | Recruiting | Medical University of Graz | 93 | 2025-11-27 | 2026-05-14 | |
| Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis Vitamin D - Neonatal Sepsis, Preterm Infants | Phase 4 | Completed | Universitas Padjadjaran | 78 | 2025-08-02 | 2026-02-05 |
| Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection Alcohol hand rub group, Chlorhexidine hand rub - Neonatal Sepsis | Not applicable | Recruiting | Alexandria University | 100 | 2025-08-01 | 2026-02-19 |
| Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates Antibiotics - Sepsis, PROM, Preterm (Pregnancy) | Phase 3 | Recruiting | Indian Council of Medical Research | 1500 | 2025-06-07 | 2026-10-27 |
| Vancomycin Reduction Practices (VRP) in the NICU External Facilitation - Antibiotic Stewardship, Neonatal Sepsis, Late-Onset | Not applicable | Recruiting | Children's Hospital of Philadelphia | 13 | 2025-06-02 | 2026-09-24 |
| Azithromycin for Preventing Maternal and Neonatal Infections During Labor. oral azithromycin, no azithromycin - Maternal and Neonatal Sepsis, Intrapartum Antibiotics | Phase 4 | Not yet recruiting | Armed Forces Hospital, Pakistan | 400 | 2025-05-01 | 2025-05-06 |
| Late-onset Sepsis and Development Test of Sensory Function in Infants, Peabody Motor Development Scale-2 - Sepsis Newborn, Motor Development | Completed | Nigde Omer Halisdemir University | 57 | 2025-03-19 | 2025-06-26 | |
| A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women GBS-NN/NN2 vaccine - Streptococcus Agalactiae Infection, Neonatal Sepsis | Phase 2 / Phase 3 | Active not recruiting | Minervax ApS | 137 | 2025-03-07 | 2026-09-04 |
| Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies - Shock, Preterm Birth Complication | Phase 4 | Active not recruiting | Coordinación de Investigación en Salud, Mexico | 76 | 2025-02-01 | 2025-11-25 |
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Sepsis (31) · Premature Birth (27) · Enterocolitis, Necrotizing (18) · Infections (9) · Fetal Membranes, Premature Rupture (8) · Perinatal Death (7) · Asphyxia Neonatorum (6) · Chorioamnionitis (6) · Pneumonia (5) · Preterm Premature Rupture of the Membranes (5) · Disease (4) · Bacterial Infections (3) · Communicable Diseases (3) · Diarrhea (3)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (188) · Pathologic Processes (188) · Pathological Conditions, Signs and Symptoms (188) · Systemic Inflammatory Response Syndrome (188) · Inflammation (187) · Infant, Newborn, Diseases (185) · Infections (179) · Sepsis (157) · Urogenital Diseases (47) · Female Urogenital Diseases and Pregnancy Complications (46) · Pregnancy Complications (43) · Obstetric Labor Complications (38) · Obstetric Labor, Premature (27) · Digestive System Diseases (18) · Enterocolitis (18)
Gentamicins (6) · Blood Culture (5) · Lactoferrin (5) · Saline Solution (4) · Ampicillin (3) · Anti-Bacterial Agents (3) · Azithromycin (3) · Chlorhexidine (3) · Pentoxifylline (3) · pentaglobulin (3) · Amikacin (2) · Amoxicillin (2) · Granulocyte Colony-Stimulating Factor (2) · Hand Hygiene (2) · Meropenem (2)
Assiut University (13) · Aga Khan University (5) · Ain Shams University (5) · Mansoura University Children Hospital (4) · Shandong University (3) · Sohag University (3) · Zekai Tahir Burak Women's Health Research and Education Hospital (3) · All India Institute of Medical Sciences (2) · Ankara University (2) · Boston University (2) · Cairo University (2) · Children's Hospital Medical Center, Cincinnati (2) · Children's Hospital of Fudan University (2) · Drugs for Neglected Diseases (2) · Fakultas Kedokteran Universitas Indonesia (2)
Egypt (20) · United States (14) · India (12) · Netherlands (9) · Pakistan (9) · Canada (8) · China (8) · Italy (8) · Turkey (Türkiye) (8) · Israel (7) · France (6) · Poland (5) · Germany (4) · Indonesia (4) · South Africa (4)
Wei Zhao, Ph.D (2) · Abbot Laptook, MD (1) · Abd Elazeez AT Shabaan, PhD (1) · Abhik Das, PhD (1) · Aleksandra M Cichonska, PhD (1) · Alessandra Coscia, MD PhD (1) · Alev Esercan (1) · Almas Aamir, MSC (1) · Amal A Soliman (1) · Amish Jain, MBBS, MRCPCH, PhD (1) · Anita KM Zaidi, MBBS, SM (1) · Anna Roca, PhD (1) · Appiah Korang Labi, MD (1) · Araceli Montoya-Estrada, PhD (1)
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K43TW010682 (1), R01HD053719 (1), R01HD067694 (1), R01HD089939 (1), R01HD097578 (1), R01NR010015 (1), U10HD036790 (1), U24HD092094 (1), UG1HD021364 (1), UG1HD027851 (1), UG1HD027853 (1), UG1HD027856 (1), UG1HD027880 (1), UG1HD027904 (1), UG1HD034216 (1)