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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.

Bleeding, sepsis, and liver impairment each independently raise thrombocytopenia risk in ICU patients
Emergency Medicine Meta-analysis
Bleeding, sepsis, and liver impairment each independently raise thrombocytopenia risk in ICU patients Critical illness factors linked to lower platelet counts in patients
This meta-analysis of 27,147 critically ill patients found that bleeding (OR 3.49), sepsis (OR 2.32), and impaired liver function (OR 1.55) …
New data shows that bleeding, sepsis, and liver issues significantly increase the risk of low platelets in critically ill patients.
Age, male sex, low BMI, and comorbidities like diabetes are significant risk factors for sepsis incidence
Diabetes & Endocrinology Meta-analysis
Age, male sex, low BMI, and comorbidities like diabetes are significant risk factors for sepsis incidence Age, diabetes, and COPD raise sepsis risk, meta-analysis finds
This meta-analysis of 21 studies identifies several significant risk factors associated with increased sepsis incidence, including age over …
A new analysis of 21 studies pinpoints key risk factors for sepsis, including age, diabetes, and COPD.
Early postnatal antibiotic exposure increases BPD risk in very preterm infants across 11 studies
Pediatrics Meta-analysis
Early postnatal antibiotic exposure increases BPD risk in very preterm infants across 11 studies Early Antibiotic Exposure Linked to Risks for Very Preterm Infants
This meta-analysis of 11 studies indicates that early postnatal antibiotic exposure is associated with an increased risk of bronchopulmonary…
Early antibiotic use in very preterm infants is linked to higher risks of lung issues, intestinal damage, and mortality.
Toll-like receptor signaling governs inflammatory phenotypes and progression in infectious myocarditis
Cardiology Sys. Review
Toll-like receptor signaling governs inflammatory phenotypes and progression in infectious myocarditis Toll-like receptors shape severity of infectious myocarditis
This systematic review examines the role of toll-like receptors (TLRs) in infectious myocarditis associated with COVID-19, influenza, and se…
A systematic review finds that pathogen-specific TLR signaling determines inflammation and outcomes in infectious myocarditis, with COVID-19…
HMGB1 and LPS interactions provide potential therapeutic targets for inflammation and coagulation in sepsis
Allergy & Immunology Sys. Review
HMGB1 and LPS interactions provide potential therapeutic targets for inflammation and coagulation in sepsis New research identifies how specific proteins drive sepsis inflammation
This narrative review explores the mechanistic roles of Lipopolysaccharide (LPS) and High Mobility Group Box 1 (HMGB1) in sepsis. The author…
Scientists have identified a specific interaction between two molecules that triggers severe inflammation and organ failure during sepsis.
Sepsis is an inflammation-driven immune reprogramming disorder characterized by time-resolved trajectories and biologically defined subtypes
Cardiology Sys. Review
Sepsis is an inflammation-driven immune reprogramming disorder characterized by time-resolved trajectories and biologically defined subtypes New research reframes sepsis as an immune reprogramming disorder
This narrative review explores the pathophysiology of sepsis as a dynamic immune reprogramming disorder involving hyperinflammation and low-…
Sepsis is more than just a severe infection; it is now being understood as a complex failure of the body's immune system.
Adrenergic receptor signaling modulates pulmonary innate immunity and barrier integrity in acute lung injury
Diabetes & Endocrinology Sys. Review
Adrenergic receptor signaling modulates pulmonary innate immunity and barrier integrity in acute lung injury Understanding How Nerve Signals Influence Lung Health During Severe Respiratory Infections
This systematic review synthesizes the role of adrenergic receptors (ARs) as a molecular interface between the sympathetic nervous system an…
New research explores how specific nerve signals help control inflammation and protect the lungs during severe lung infections.
Hyperoxygenation target (PaO2: 100-150 mmHg) reduces 28-day mortality in patients with sepsis
Emergency Medicine RCT
Hyperoxygenation target (PaO2: 100-150 mmHg) reduces 28-day mortality in patients with sepsis Higher oxygen targets may lower death rates for sepsis patients
This randomized controlled trial of 270 patients with sepsis found that a hyperoxygenation target of PaO2: 100-150 mmHg significantly reduce…
A new trial shows that giving higher levels of oxygen to patients with sepsis can significantly reduce deaths within the first 28 days.
Lactobacillus rhamnosus GG does not significantly impact composite outcomes in VLBW infants
Pediatrics RCT
Lactobacillus rhamnosus GG does not significantly impact composite outcomes in VLBW infants Trial shows probiotic LGG does not improve outcomes for infants
This randomized controlled trial of 236 enterally-fed very low birth weight infants found no significant difference in the primary composite…
A trial of 236 very low birth weight infants found that a specific probiotic did not reduce risks like sepsis or intestinal issues.
Novel biomarkers and machine learning algorithms facilitate earlier identification and diagnosis of sepsis
Infectious Disease Sys. Review
Novel biomarkers and machine learning algorithms facilitate earlier identification and diagnosis of sepsis New Diagnostic Tools May Help Identify Sepsis More Quickly
This narrative review explores the evolution of sepsis diagnostic strategies from traditional clinical scoring systems to advanced markers l…
Newer biomarkers and machine learning tools are evolving beyond traditional scoring systems to help doctors identify sepsis earlier in patie…
Bovine milk fortifiers non-inferior to human milk fortifiers for NEC and sepsis in pre-term newborns
Nutrition & Obesity Medicine Meta-analysis
Bovine milk fortifiers non-inferior to human milk fortifiers for NEC and sepsis in pre-term newborns Bovine Milk Fortifiers Show Similar Results to Human Milk
This meta-analysis of 3371 publications found that bovine milk-based fortifiers are non-inferior to human milk-based fortifiers for necrotiz…
A large review of research suggests that bovine milk based fortifiers are as safe and effective as human milk for newborns with specific con…
Elevated HMGB1 levels correlate with sepsis diagnosis and increased mortality risk in adult patients
Emergency Medicine Meta-analysis
Elevated HMGB1 levels correlate with sepsis diagnosis and increased mortality risk in adult patients High HMGB1 levels linked to sepsis and higher mortality
This meta-analysis of 3,110 patients found that serum or plasma HMGB1 levels are significantly higher in sepsis patients compared to healthy…
Higher levels of the protein HMGB1 in the blood are linked to more severe cases of sepsis and an increased risk of death for patients.

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 →