Neonatal Sepsis clinical trials
The registry lists 192 studies for Neonatal Sepsis across more than 10 countries. 41 are recruiting or about to start. 135 of them are mainly about Neonatal Sepsis (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-06.
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Who runs them
Assiut University (13) · Ain Shams University (6) · Aga Khan University (5) · Mansoura University Children Hospital (4) · Zekai Tahir Burak Women's Health Research and Education Hospital (3) · Shandong University (3) · Sohag University (3) · Fakultas Kedokteran Universitas Indonesia (2)
What is being tested here
Drugs under test in Neonatal Sepsis studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Gentamicins | 1 | 3 | 5 |
| Ampicillin | 1 | 1 | 3 |
| Azithromycin | 1 | 2 | 3 |
| Methylene Blue | 1 | 1 | 2 |
| Acetylcysteine | 1 | 1 | 1 |
| Cholecalciferol | 1 | 0 | 1 |
| Lactoferrin | 0 | 0 | 4 |
| Chlorhexidine | 0 | 2 | 4 |
| Pentoxifylline | 0 | 2 | 3 |
| BOS taurus colostrum | 0 | 0 | 3 |
Drug classes tested here Beta-lactamase inhibitors 1 open
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
The 10 nearest
- Nov 2026Molecular Culture for the Diagnosis of Pediatric Sepsis · Jip Groen
- Jan 2027Presepsin to Safely Reduce Antibiotics in Preterm Infants · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Jan 2027Wireless MicroPremVitals Button Sensor in the NICU · McGill University Health Centre/Research Institute of the McGill University Health Centre
- Jan 2027PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes · Sarawak General Hospital
- Mar 2027G-CSF In Neonatal Sepsis With Neutropenia · University of Health Sciences Lahore
- May 2027Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS · Hospices Civils de Lyon
- Jun 2027Cahnge in Management of Suspected Early Onset Neonetal Sepsis After Assimilation of Early Onset Sepsis Calculator · Hillel Yaffe Medical Center
- Jun 2027Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis · Mount Sinai Hospital, Canada
- Jul 2027MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates · Tanta University
- Aug 2027CBC Indices and Serum Lactate in Neonatal Sepsis · Assiut University
Who these studies take
Of the 23 Neonatal Sepsis studies recruiting now, 8 (35%) set no upper age limit and 15 (65%) stop at 75 or younger. 20 (87%) take children under 18. 3 (13%) are for women only and 0 (0%) for men only; 2 (9%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 6 (26%) | 5 (22%) |
| 18 | 10 (43%) | 7 (30%) |
| 30 | 9 (39%) | 6 (26%) |
| 40 | 9 (39%) | 6 (26%) |
| 50 | 9 (39%) | 6 (26%) |
| 65 | 9 (39%) | 6 (26%) |
| 75 | 8 (35%) | 5 (22%) |
| 85 | 8 (35%) | 5 (22%) |
Across all 192 studies, recruiting or not: 80% stop at 75 or younger and 80% at 65; 92% take children; 13% are for women only and 0% for men only; 24% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Neonatal Sepsis studies take
Of 38 observational studies under Neonatal Sepsis, half reached primary completion within 25 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Interventional, no phase | 21 mo11–35 · 30 studies | — | — |
| Observational | 25 mo16–47 · 38 studies | — | 28 mo16–47 · 37 studies |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
What changed recently
From the registry's own updates since Oct 13, 2026.
Started recruiting1
Newly registered2
- A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation TrialNov 6, 2026NCT07922226
- G-CSF In Neonatal Sepsis With NeutropeniaOct 22, 2026NCT07888829
Studies
Recruiting first, then most recently updated. Showing 50 of 192. Browse all 192 → or search them.
- A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation TrialNot yet recruitingNCT07922226Phase 2/3
- Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm NeonatesRecruitingNCT06377397Phase 31 country
- G-CSF In Neonatal Sepsis With NeutropeniaNot yet recruitingNCT07888829Not applicable1 country
- Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset SepsisRecruitingNCT053472385 countries
- Vancomycin Reduction Practices (VRP) in the NICURecruitingNCT06772675Not applicable1 country
- Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionSRecruitingNCT060588191 country
- MDW as a Novel Diagnostic Biomarker in LONS Among Preterm NeonatesRecruitingNCT078211901 country
- T6A Biomarker for Detection of Bacterial Infection in Newborn InfantsRecruitingNCT076706242 countries
- Wireless MicroPremVitals Button Sensor in the NICURecruitingNCT07732257Not applicable1 country
- CBC Indices and Serum Lactate in Neonatal SepsisNot yet recruitingNCT07663084
- The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in NeonatesRecruitingNCT071098561 country
- Neonatal Catheter Lock for Infection PreventionNot yet recruitingNCT07585188Not applicable1 country
- Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal SepsisNot yet recruitingNCT075729161 country
- PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of MembranesNot yet recruitingNCT07563504Phase 41 country
- Cahnge in Management of Suspected Early Onset Neonetal Sepsis After Assimilation of Early Onset Sepsis CalculatorNot yet recruitingNCT066430521 country
- Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated InfectionRecruitingNCT07421323Not applicable1 country
- Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal SepsisNot yet recruitingNCT07380347Phase 3
- Presepsin to Safely Reduce Antibiotics in Preterm InfantsRecruitingNCT06100614Not applicable1 country
- Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset SepsisRecruitingNCT068453321 country
- Amniotic Fluid & the Preterm GutRecruitingNCT071521061 country
- Azithromycin for Preventing Maternal and Neonatal Infections During Labor.Not yet recruitingNCT06958146Phase 4
- Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal SepsisNot yet recruitingNCT066337701 country
- Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and ZimbabweRecruitingNCT064114052 countries
- Molecular Culture for the Diagnosis of Pediatric SepsisRecruitingNCT060187921 country
- Intravenous Methylene Blue for Treating Refractory Neonatal Septic ShockNot yet recruitingNCT06306001Phase 2/31 country
- Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis CalculatorRecruitingNCT05274776Not applicable1 country
- The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.Not yet recruitingNCT06199102Not applicable1 country
- Metagenomic Next-Generation Sequencing Guides Anti-Infection StrategiesRecruitingNCT061458411 country
- The Effect of Probiotics Added to the Mother's Diet on Preterm BabiesNot yet recruitingNCT06118801Not applicable
- Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal SepsisNot yet recruitingNCT06113653
- Probiotic Supplementation in Extremely Preterm Infants in ScandinaviaRecruitingNCT05604846Not applicable1 country
- Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal PopulationsRecruitingNCT060762001 country
- Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in ChinaNot yet recruitingNCT05089760
- Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal SepsisNot yet recruitingNCT05985174Not applicable1 country
- Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal SepsisRecruitingNCT05991648Not applicable1 country
- Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.RecruitingNCT05981079Phase 41 country
- Frequency and Severity of Thrombocytopenia in Neonatal SepsisNot yet recruitingNCT05692128
- Molecular Culture for the Diagnosis of Neonatal SepsisRecruitingNCT057636801 country
- PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOSNot yet recruitingNCT05796115Not applicable
- Using Antibiotics Wisely - An Antimicrobial Stewardship ProgramRecruitingNCT043882931 country
- Antibiotic Therapy for Early Onset Neonatal SepsisRecruitingNCT039321231 country
- Topical Coconut Oil Application and Incidence of Sepsis in NeonatesCompletedNCT04842786Not applicable1 country
- A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant WomenActive, not recruitingNCT06592586Phase 2/32 countries
- Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm BabiesCompletedNCT077653291 country
- Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal SepsisCompletedNCT036235031 country
- Late-Onset Neonatal Sepsis: A Case-Control StudyCompletedNCT076352641 country
- NICU Antibiotics and Outcomes TrialCompletedNCT03997266Phase 41 country
- Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKIWithdrawnNCT05114057Not applicable1 country
- Microfluidic Assessment of Clinical Outcomes in Preterm NewbornsActive, not recruitingNCT032914961 country
- Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal SepsisCompletedNCT07245277Phase 41 country