Neonatal sepsis
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Summary
Neonatal sepsis (MONDO:0700217) is a disease and 88 clinical trials. Top therapeutic interventions include methylene blue cation, amoxicillin, and ceftobiprole medocaril free acid. A subtype of bacterial infectious disease with sepsis — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Clinical trials: 88
Clinical features
No curated clinical features (Orphanet) for this disease.
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | neonatal sepsis |
| Mondo ID | MONDO:0700217 |
| UMLS | C0456103 |
| MedGen | 96816 |
| Is cancer (heuristic) | no |
Disease family
This is a subtype of bacterial infectious disease with sepsis. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by etiologic mechanism › disease of primarily extrinsic mechanism › infectious disease › bacterial infectious disease › bacterial infectious disease with sepsis › neonatal sepsis
Related subtypes (4): gas gangrene, Pasteurella hemorrhagic septicemia, Lemierre syndrome, meningococcemia
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
No druggable-target or therapeutic data for this disease’s cohort.
Clinical trials & evidence
Clinical trials
Clinical trials: 88.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| Not specified | 62 |
| PHASE3 | 10 |
| PHASE4 | 5 |
| PHASE2/PHASE3 | 3 |
| PHASE2 | 3 |
| PHASE1 | 2 |
| EARLY_PHASE1 | 2 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT01479114 | PHASE4 | COMPLETED | Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates |
| NCT02959229 | PHASE4 | COMPLETED | Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis |
| NCT03247920 | PHASE4 | COMPLETED | Reduction of Intravenous Antibiotics In Neonates |
| NCT03403530 | PHASE4 | COMPLETED | Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates |
| NCT07245277 | PHASE4 | COMPLETED | Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis |
| NCT06306001 | PHASE2/PHASE3 | NOT_YET_RECRUITING | Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock |
| NCT06592586 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women |
| NCT07380347 | PHASE3 | NOT_YET_RECRUITING | Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal Sepsis |
| NCT01027429 | PHASE3 | COMPLETED | Simplified Antibiotic Therapy for Sepsis in Young Infants |
| NCT01177111 | PHASE3 | COMPLETED | Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal |
| NCT01723501 | PHASE2/PHASE3 | WITHDRAWN | Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth |
| NCT02954926 | PHASE3 | COMPLETED | Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis |
| NCT03199547 | PHASE3 | COMPLETED | Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death |
| NCT03280147 | PHASE3 | COMPLETED | 7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis |
| NCT03431558 | PHASE3 | UNKNOWN | Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies. |
| NCT03871491 | PHASE3 | COMPLETED | Azithromycin-Prevention in Labor Use Study (A-PLUS) |
| NCT04172012 | PHASE3 | COMPLETED | Use of Probiotics to Reduce Infections, Death and ESBL Colonisation |
| NCT05856227 | PHASE3 | COMPLETED | Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age |
| NCT03295162 | PHASE1/PHASE2 | COMPLETED | Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis |
| NCT03453177 | PHASE2 | COMPLETED | Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis |
| NCT04110418 | PHASE2 | UNKNOWN | Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate |
| NCT06002295 | PHASE2 | COMPLETED | A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns |
| NCT00942084 | PHASE1 | COMPLETED | A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo) |
| NCT04474327 | PHASE1 | COMPLETED | Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants |
| NCT01821989 | EARLY_PHASE1 | UNKNOWN | Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate |
| NCT04094597 | EARLY_PHASE1 | COMPLETED | Safety and Efficacy of Oral Bovine Lactoferrin |
| NCT03291496 | Not specified | ACTIVE_NOT_RECRUITING | Microfluidic Assessment of Clinical Outcomes in Preterm Newborns |
| NCT06633770 | Not specified | NOT_YET_RECRUITING | Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis |
| NCT07421323 | Not specified | RECRUITING | Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection |
| NCT00800449 | Not specified | COMPLETED | Distribution of Haptoglobin Phenotype in Septic and Non Septic Pre-term Neonates (PTSH) |
| NCT00861055 | Not specified | COMPLETED | Neonatal Sepsis and GBS Carriage Study |
| NCT00866567 | Not specified | COMPLETED | Defects in Opsonophagocytosis in Premature Infants |
| NCT00947518 | Not specified | COMPLETED | Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants |
| NCT01005589 | Not specified | COMPLETED | CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis |
| NCT01120678 | Not specified | COMPLETED | Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay |
| NCT01214473 | Not specified | TERMINATED | Probiotics for Prevention Neonatal Infection |
| NCT01290003 | Not specified | COMPLETED | Role of Antibiotics in Preventing Infection in Babies Born Through Meconium Stained Liquor |
| NCT01294865 | Not specified | UNKNOWN | Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis |
| NCT01350765 | Not specified | COMPLETED | Naushero Feroze Neonatal Survival Project |
| NCT01539356 | Not specified | COMPLETED | Hepcidin Levels in Preterm Infants |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| METHYLENE BLUE CATION | 4 | 6 |
| AMOXICILLIN | 4 | 2 |
| CEFTOBIPROLE MEDOCARIL FREE ACID | 4 | 2 |
| CHLORHEXIDINE | 4 | 2 |
| ACYCLOVIR | 4 | 1 |
| AMIKACIN | 4 | 1 |
| CLAVULANIC ACID | 4 | 1 |
| FOSFOMYCIN | 4 | 1 |
| GENTAMICIN | 4 | 1 |
| PENICILLIN G PROCAINE | 4 | 1 |
| PIPERACILLIN | 4 | 1 |
| WATER | 4 | 1 |
| MALTODEXTRIN | 3 | 1 |
| CHEMBL195892 | 0 | 1 |
| CHEMBL3039597 | 0 | 1 |
| CHEMBL6175829 | 0 | 1 |
| CHEMBL5430305 | 0 | 1 |
| CHEMBL4793445 | 0 | 1 |
| GENTAMICIN C1A | 0 | 1 |
| GENTAMICIN C2 | 0 | 1 |
| INTERLEUKIN 6 | 0 | 1 |