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Neonatal Sepsis

Part of Systemic Inflammatory Response Syndrome

Subtypes of Neonatal Sepsis

Early-onset sepsis (EOS) 1 Neonatal mortality/sepsis 1 Uncomplicated neonatal sepsis 1

10 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Neonatal Sepsis

7 trials tracked for Neonatal Sepsis: 3 in phase 3 or 4 and 2 with published results. The most-cited published study has 11 citations.

7Trials tracked
3Phase 3 & 4
0Recruiting
2With published results
Phase distribution
Phase 4 1 Phase 3 2 Phase 1 1 Other / NA 3
  1. Phase 3 Azithromycin-Prevention in Labor Use Study (A-PLUS) Completed · 11 cited
  2. Phase 4 Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis Completed
  3. Phase 3 Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age Completed
  4. Phase 1 A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo) Completed
  5. N/A Smart Discharges for Mom & Baby Completed
  6. N/A Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants Completed
Show 1 more trials
  1. N/A Optimising Newborn Nutrition During Therapeutic Hypothermia. Completed

Showing the 7 most-cited and recently-updated of 7 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Neonatal Sepsis: what the trials found

New evidence indicates that Vitamin D significantly impacts clinical scores and inflammatory markers in sepsis cases, with significant improvements observed in the Modified Töllner Sepsis Scoring System (p<0.001), the Sepsis Prediction Score (p<0.001), and C-Reactive Protein levels (p=0.030) 1.

Regarding maternal health, Azithromycin was evaluated for its impact on outcomes following delivery; while it showed a statistically significant difference in preventing maternal death or sepsis within 6 weeks (p<0.001), there was no significant difference in intrapartum/neonatal death or sepsis within 4 weeks (p=0.56) 2. Ceftobiprole medocaril has also been evaluated in phase 3 clinical settings 3.

For the clinician treating this condition

  • Vitamin D administration is associated with statistically significant improvements in both standardized sepsis scoring systems and C-reactive protein levels.
  • Azithromycin shows a statistically significant impact on preventing maternal death or sepsis within a 6-week post-delivery window, though it does not significantly alter intrapartum/neonatal outcomes within 4 weeks.

AI synthesis of 3 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.

Research across Systemic Inflammatory Response Syndrome

Related studies from across the Systemic Inflammatory Response Syndrome family.

Sivelestat-containing regimens reduce all-cause mortality in sepsis-induced ARDS with OR 0.55
Rheumatology Meta-analysis
Sivelestat-containing regimens reduce all-cause mortality in sepsis-induced ARDS with OR 0.55 Sivelestat shows lower mortality for patients with sepsis and ARDS
This meta-analysis of 943 patients found that a sivelestat-containing regimen significantly reduced all-cause mortality in sepsis-induced AR…
A new review of data suggests the drug sivelestat may lower death rates for adults with severe lung and blood infections.
High THBS1 expression is associated with poorer outcomes in patients with sepsis
Infectious Disease Meta-analysis
High THBS1 expression is associated with poorer outcomes in patients with sepsis High THBS1 levels linked to poorer outcomes in sepsis patients
This meta-analysis of public datasets and an exploratory cohort identifies THBS1 as a candidate molecule for myeloid immune responses in sep…
A new look at medical data shows that high levels of a specific protein marker may signal a higher risk for sepsis patients.
AI decision support improves detection in bounded tasks but not in open-ended reasoning
Drug Pipeline Sys. Review
AI decision support improves detection in bounded tasks but not in open-ended reasoning AI Tools Show Mixed Results in Cancer and Sepsis Detection
This narrative review examines the impact of AI decision support and large language models on clinician performance in cancer and sepsis. Th…
AI tools may help doctors find more cancer and reduce workload, but they do not improve complex reasoning or always ensure consistent accura…
Heparin Shows No Mortality Benefit in Sepsis Meta-Analysis of 426 Patients
Drug Pipeline Meta-analysis
Heparin Shows No Mortality Benefit in Sepsis Meta-Analysis of 426 Patients Heparin treatment shows mixed results for patients with sepsis
This meta-analysis examined heparin use in critically ill patients with sepsis, pooling data from 426 patients. No significant mortality red…
New data on heparin for sepsis shows it does not significantly reduce death rates, and its role in blood clotting remains unclear.
MitoQ acts as an upstream mitochondrial redox modulator to attenuate oxidative injury in SALI
Drug Pipeline Sys. Review
MitoQ acts as an upstream mitochondrial redox modulator to attenuate oxidative injury in SALI MitoQ may protect lung cells from damage during severe infection
This narrative review explores the role of MitoQ in treating sepsis and acute lung injury. The authors suggest MitoQ may mitigate mitochondr…
A new review suggests the compound MitoQ could protect lung tissue and energy production during severe infections like sepsis.
Hemodiafiltration in Neonates: Narrative Review Maps Applications but Reports No Clinical Outcomes
Pediatrics Sys. Review
Hemodiafiltration in Neonates: Narrative Review Maps Applications but Reports No Clinical Outcomes Hemodiafiltration in Babies: What We Still Do Not Know
This narrative review examines hemodiafiltration (HDF) in neonates and infants, focusing on clinical applications, potential benefits, safet…
A new review looks at hemodiafiltration for newborns and infants, but reports no actual results or safety data.
Higher H3.1 nucleosome levels associate with 48% increased 28-day mortality in septic shock
Emergency Medicine RCT
Higher H3.1 nucleosome levels associate with 48% increased 28-day mortality in septic shock H3.1 Nucleosome Levels Linked to Sepsis Mortality and Kidney Risk
This secondary analysis of a multicenter randomized controlled trial involved 971 patients with sepsis and septic shock. Higher plasma H3.1 …
Higher levels of H3.1 nucleosomes in patients with sepsis and septic shock are linked to a higher risk of death and need for kidney replacem…
Phoenix Sepsis Criteria outperforms IPSCC criteria for pediatric in-hospital mortality risk stratification
Emergency Medicine Meta-analysis
Phoenix Sepsis Criteria outperforms IPSCC criteria for pediatric in-hospital mortality risk stratification New criteria improve risk prediction for children with sepsis
This meta-analysis of 15 studies and 16 cohorts involving 2,601,038 encounters evaluates the Phoenix Sepsis Criteria (PSC) compared to IPSCC…
A new scoring system helps doctors better predict which children with severe infections are at the highest risk of dying in the hospital.
Feasibility study for meropenem versus piperacillin/tazobactam in sepsis shows 30.5% 30-day mortality
Infectious Disease RCT
Feasibility study for meropenem versus piperacillin/tazobactam in sepsis shows 30.5% 30-day mortality Trial Tests Meropenem for Treatment of Sepsis in Critical Care
This feasibility study of 200 critically ill adults with sepsis in 10 Danish ICUs evaluated the trial's operational viability. The study rep…
A new feasibility study explores the use of meropenem to treat critically ill adults suffering from sepsis in intensive care units.
Sepsis-associated delirium affects 43% of ICU patients, mechanical ventilation strongest risk factor
Emergency Medicine Meta-analysis
Sepsis-associated delirium affects 43% of ICU patients, mechanical ventilation strongest risk factor Risk Factors Linked to Delirium in Patients with Sepsis
This meta-analysis of 89,789 ICU patients estimates the pooled incidence of sepsis-associated delirium (SAD) at 43% (95% CI 39%-47%). Higher…
A large review of ICU patients identifies key risk factors, such as advanced age and mechanical ventilation, for developing delirium during …
Elevated BMI is associated with lower short-term and long-term mortality in adult sepsis patients
Emergency Medicine Meta-analysis
Elevated BMI is associated with lower short-term and long-term mortality in adult sepsis patients Higher BMI Linked to Lower Mortality in Patients with Sepsis
This meta-analysis of 130755 patients indicates that an elevated BMI (≥30 kg/m) is associated with significantly lower short-term and long-t…
A large review of data suggests that patients with a higher BMI may have lower mortality rates when treated for sepsis.
Mongolian Medicine Compounds Show Immunomodulatory Potential in Sepsis, But Direct Evidence Remains Scarce
Diabetes & Endocrinology Sys. Review
Mongolian Medicine Compounds Show Immunomodulatory Potential in Sepsis, But Direct Evidence Remains Scarce Traditional Mongolian Medicine shows potential for treating sepsis models
This narrative review examines Traditional Mongolian Medicine compounds (Daruqi particles, HHQG, Hohgardi-9, Nagab-9, Monflu, Batri-7, Qiqir…
Traditional Mongolian medicines like quercetin and berberine show potential to manage inflammation in sepsis models, though more human trial…

Questions about Neonatal Sepsis

Does reducing antibiotic use help lower neonatal sepsis mortality rates?

Reducing unnecessary antibiotic use through antimicrobial stewardship strategies in newborns can lower both antibiotic exposure and mortality rates, especially in low-resource settings.

Full answer →
Does maternal preeclampsia increase the risk of neonatal sepsis in my baby?

Yes, maternal preeclampsia is linked to a modestly higher risk of neonatal sepsis in the first 28 days of life, based on a large meta-analysis.

Full answer →