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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.

Gut-kidney axis drives sepsis-associated AKI, review argues for microecological and neuromodulatory therapies
Nephrology Sys. Review
Gut-kidney axis drives sepsis-associated AKI, review argues for microecological and neuromodulatory therapies New Approaches Target Gut Health to Treat Sepsis Kidney Damage
This systematic review examines the gut-kidney axis as a mechanistic driver of sepsis-associated acute kidney injury and evaluates microecol…
New research explores how targeting the gut-kidney axis could help treat and prevent kidney damage in patients with sepsis.
Admission hypoalbuminemia is associated with increased mortality and acute kidney injury in burn patients
Emergency Medicine Meta-analysis
Admission hypoalbuminemia is associated with increased mortality and acute kidney injury in burn patients Low Serum Albumin Linked to Higher Mortality in Burn Patients
This meta-analysis of 9 studies indicates that hypoalbuminemia on admission is significantly associated with increased mortality (OR 9.51) a…
Low serum albumin levels at the time of admission are linked to a higher risk of death and kidney damage in patients with burn injuries.
Intravenous vitamin C associated with reduced mortality in patients with sepsis and septic shock
Nutrition & Obesity Medicine Meta-analysis
Intravenous vitamin C associated with reduced mortality in patients with sepsis and septic shock Vitamin C May Reduce Mortality in Patients with Sepsis
This meta-analysis evaluated the impact of intravenous vitamin C on outcomes for patients with sepsis or septic shock. The authors observed …
A review of data suggests intravenous vitamin C may lower death rates for patients with sepsis, though the evidence quality remains low.
Early Feeding in VLBW Infants Safe, Cuts Sepsis Risk
Emergency Medicine Meta-analysis
Early Feeding in VLBW Infants Safe, Cuts Sepsis Risk Early feeding may reduce sepsis in very low birth weight infants
Meta-analysis finds early enteral feeding in VLBW infants reduces sepsis and time to full feeds without increasing NEC or mortality.
Early feeding within 72 hours may help very low birth weight infants reach full nutrition faster and reduce the risk of sepsis.
Higher PNI scores are associated with lower short-term mortality in patients with sepsis
Nutrition & Obesity Medicine Meta-analysis
Higher PNI scores are associated with lower short-term mortality in patients with sepsis Nutritional scores help identify patients at risk from sepsis
This meta-analysis of 34,810 patients evaluated various nutritional assessment tools for sepsis mortality. Higher PNI scores were associated…
New data shows that specific nutritional assessment tools can help doctors identify which sepsis patients are at the highest risk for death.
Butyrylcholinesterase activity predicts in-hospital mortality in critically ill adults with sepsis
Emergency Medicine Meta-analysis
Butyrylcholinesterase activity predicts in-hospital mortality in critically ill adults with sepsis Butyrylcholinesterase levels help predict survival in patients with sepsis
This individual participant data meta-analysis of 482 critically ill adults with sepsis found that higher Day-1 butyrylcholinesterase (BChE)…
Doctors may soon use butyrylcholinesterase levels to better predict which critically ill patients with sepsis are at higher risk of dying.
Elevated syndecan-1 levels correlate with severity and poor outcomes in patients with sepsis
Hematology Meta-analysis
Elevated syndecan-1 levels correlate with severity and poor outcomes in patients with sepsis Higher syndecan-1 levels linked to severe sepsis and poor outcomes
This meta-analysis of 4985 patients, including 3902 with sepsis, found significantly higher circulating syndecan-1 levels in sepsis patients…
A new analysis shows that higher levels of a specific protein can help doctors identify patients with the most severe forms of sepsis.
Balanced crystalloid solutions reduce mortality and acute kidney injury in adult patients with sepsis
Rheumatology Meta-analysis
Balanced crystalloid solutions reduce mortality and acute kidney injury in adult patients with sepsis Balanced crystalloid solutions show lower death rates in sepsis patients
This meta-analysis of 7 trials involving 8,173 adults with sepsis found that balanced crystalloids significantly reduced mortality (RR 0.92)…
A large review of over 8,000 patients suggests balanced crystalloid fluids may reduce mortality and kidney damage for those with sepsis.
Mitochondrial dysfunction shapes immune cell function across sepsis phases, review finds
Allergy & Immunology Sys. Review
Mitochondrial dysfunction shapes immune cell function across sepsis phases, review finds Mitochondrial Function Shapes Immune Response During Sepsis
This mini-review synthesizes evidence on mitochondrial immunometabolism in sepsis, describing how bioenergetic dysfunction and quality-contr…
New research highlights how mitochondrial health impacts immune cell function and organ damage during different stages of sepsis.
Five pathways drive sepsis-induced cardiomyopathy; imaging and biomarker panels improve early diagnosis
Cardiology Meta-analysis
Five pathways drive sepsis-induced cardiomyopathy; imaging and biomarker panels improve early diagnosis New Strategies for Managing Sepsis Induced Heart Damage
This systematic review synthesizes current knowledge on sepsis-induced cardiomyopathy (SIC), identifying five major pathological pathways th…
Newer imaging tools and biomarker panels help doctors identify heart damage from sepsis earlier to move toward more precise, targeted treatm…
Low-dose corticosteroids reduce 90-day mortality in adults with severe community-acquired pneumonia
Pulmonology & Critical Care Meta-analysis
Low-dose corticosteroids reduce 90-day mortality in adults with severe community-acquired pneumonia Low dose steroids may lower death rates in severe lung infections
This meta-analysis of 4,622 patients found that low-dose corticosteroids (≤400 mg hydrocortisone-equivalent daily) significantly reduced sho…
A review of clinical trials suggests that low-dose corticosteroids can reduce 90-day mortality for adults with severe lung infections like p…
Neonatal neutrophil function varies by assay; chemotaxis and NETs often constrained
Infectious Disease Sys. Review
Neonatal neutrophil function varies by assay; chemotaxis and NETs often constrained Understanding How Immune Cells Protect Newborns from Serious Infections
This mini review synthesizes human neonatal studies on neutrophil function. Chemotaxis and extracellular-trap formation are often developmen…
New research looks at how white blood cells in babies fight infections while trying to avoid causing tissue damage.

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 →