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Disease

Neonatal Sepsis

Late-stage therapeutic developmentEmerging research
MeSHNeonatal Sepsis
1
Publications
14
Clinical trials
2025
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 1 clinical trial expected to report results, the earliest in Q2 2029.
Upcoming Milestones
Clinical Milestones4View
Results posted 1
Results expected 1
Recently completed 2
Activity timeline4

Clinical trials

11 sponsors · 0 new · 1 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
14
All trials
3
Active
9
Late-stage
6
Completed
Late-stage studies

A Follow-up Trial to Assess the Persistence of the Immune Response to the Group B Streptococcus Vaccine (GBS-NN/NN2) After a Primary Vaccination of Healthy Pregnant Women, and to Assess Safety, Reactogenicity, and Immunogenicity of the GBS-NN/NN2 Vaccine When Administered During Follow-Up as a 1 Booster Dose During a New Pregnancy

Phase 2/3 · Active, not recruiting · Minervax ApS

Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 g

Phase 4 · Active, not recruiting · Coordinación de Investigación en Salud, Mexico

Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)

Phase 3 · Completed · Ain Shams University

The Effect of Vitamin D Administration on Sepsis Score and C-Reactive Protein Levels in Preterm Infants With Neonatal Sepsis

Phase 4 · Completed · Universitas Padjadjaran

Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis: A Randomized Control Trial

Phase 3 · Completed · Mansoura University

A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

Phase 3 · Completed · Basilea Pharmaceutica
Recently completed

The Effect of Vitamin D Administration on Sepsis Score and C-Reactive Protein Levels in Preterm Infants With Neonatal Sepsis

Phase 4 · Completed · Universitas Padjadjaran

A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

Phase 3 · Completed · Basilea Pharmaceutica

Use of Probiotics to Reduce Infections and Death and Prevent Colonization With Extended-spectrum Beta-lactamase Producing Bacteria, Among Newborn Infants in Haydom and Surrounding Area, Tanzania, a Randomized Controlled Clinical Trial

Phase 3 · Completed · Haydom Lutheran Hospital

Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)

Phase 3 · Completed · Ain Shams University

Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis: A Randomized Control Trial

Phase 3 · Completed · Mansoura University

Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial

Phase 3 · Completed · Hospital Italiano de Buenos Aires

Research activity

1 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Major themes5
  • Cell-Free Nucleic Acids1
  • DNA, Bacterial1
  • High-Throughput Nucleotide Sequencing1
  • Neonatal Sepsis1
  • Sepsis1
Leading journals1
  • Pediatric research1
Leading researchers8
  • Balks J1
  • Glaser K1
  • Grumaz S1
  • Kipfmueller F1
  • Lemloh L1
  • Mazzitelli S1
  • Melaku T1
  • Mueller A1
Affiliations (unnormalised)3
  • Children's Hospital1
  • Institute of Medical Microbiology1
  • University Medical Center Leipzig1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Blood infection that occurs in an infant younger than 90 days old. Early-onset sepsis is seen in the first week of life and most often appears within 24 hours of birth. Late-onset occurs after 1 week and before 3 months of age.

Identifiers
MeSHNeonatal Sepsis
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.