N/A N=121 Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Sepsis
Primary: Antibiotic Treatment for More Than 72 Hours — 33; 55 participants — p=0.002
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=65 Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
Preterm Infant · Early-Onset Neonatal Sepsis · Umbilical Cord
Primary: White Blood Cell Count (WBC) (1) — 8257 ratio of cells/mm3
Phase 3 N=9 Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
Neonatal Sepsis
Primary: Number of Patients With Adverse Events (AEs) — 3; 3; 0; 0 Participants
N/A N=21 Inflammatory Cytokine Quantification in Infants
Sepsis · Congenital Diaphragmatic Hernia · Neonatal Cardiopulmonary Failure
Primary: TNF-alpha, Baseline — 8.88 pg/mL
Phase 2 N=98 Antibiotic "Dysbiosis" in Preterm Infants
Enterocolitis, Necrotizing · Bacteremia · Bronchopulmonary Dysplasia
Primary: Number of Events of Composite Morbidities and Mortality, Including Necrotizing Enterocolitis (NEC), Late Onset Sepsis (LOS), Bronchopulmonary Dysplasia (BPD) and Death…
Phase 1 N=32 Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Sepsis
Primary: Piperacillin Pharmacokinetics (PK) — 0.0799 L/hr/kg
Phase 3 N=1,579 Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Staphylococcal Sepsis
Primary: The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. — 85; 79 Participants
N/A N=144 Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Sepsis · Necrotising Enterocolitis Neonatal
Primary: Number of Participants With Sepsis or Necrotizing Enterocolitis — 20; 124 Participants
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
Phase 3 N=362 Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
Candidiasis
Primary: Death or Candidiasis — 31; 37 participants
Phase 1 N=44 Intestinal Permeability in Preterm Infants
Prematurity · Intestinal Permeability
Primary: Intestinal Permeability — 0.0731; 0.0720 ratio — p=0.932
Phase 4 N=78 Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis
Neonatal Sepsis · Preterm Infants
Primary: Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days — 7; 7; 8; 9 Score — p=<0.001
Phase 1 N=24 Metronidazole Pharmacokinetics (PK) in Premature Infants
Serious Systemic Infections · Necrotizing Enterocolitis
Primary: Area Under the Curve at Steady State — 178.0 mg*hr/L
N/A N=97,507 Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Neonatal Death · Prematurity
Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants
Phase 4 N=52 Early Sodium Intake in Preterm Newborns
Hyponatremia · Premature
Primary: Hyponatremia — 6; 1 Participants — p=0.71
N/A N=185 Algorithm for Predicting the Unfavorable Course of Sepsis in Children
Sepsis
Primary: Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes — 16.0; 11.2; 11.9; 4.9 10^9 cells/l — p=<0.05
Phase 2 N=134 Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Feeding; Difficult, Newborn · Growth Failure · Necrotizing Enterocolitis
Primary: Time to Establish Full Enteral Feeds — 15; 15 days
N/A N=90 Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics
Infectious Diseases
Primary: Number of Patients With (NEC) — 0; 1 participants
N/A N=3,003 Impact of Heart Rate Characteristics Monitoring in Neonates
Sepsis
Primary: Number of Ventilator-free Days — 95.9; 93.6 days — p=0.08
Phase 2 N=106 Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Neonatal Seizures
Primary: Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) — 15; 24 Participants — p=<0.001
N/A N=529 Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
Infant, Newborn · Infant, Low Birth Weight · Infant, Small for Gestational Age
Primary: Death or Neurodevelopmental Impairment (NDI) — 44; 46; 27; 28 Participants — p=0.03
N/A N=18,693 Paediatric Rapid Sepsis Trigger (PRST) Tool
Sepsis · Infection
Primary: Time to Administration of an Appropriate Antimicrobial — 115; 123; 239; 261 minutes
Phase 4 N=2,634 Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
Sepsis · AKI · Neurotoxicity
Primary: Acute Kidney Injury (AKI) Ordinal Scale — 910; 952; 86; 100 Participants
Phase 1 N=7 Valacyclovir in Neonatal Herpes Simplex Virus Disease
Neonatal Herpes Simplex Infection
Primary: Area Under the Curve Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours — 28.8 mgxh/l
N/A N=106,629 Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Sepsis
Primary: Door-to-antibiotic Time — 160; 146; 139; 140 minutes — p=<0.001
N/A N=226 Utility of Presepsin in Distinguishing Between Sepsis and SIRS
SIRS · Sepsis
Primary: Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis — 0.7218; 0.6901…
N/A N=63 Prospective Research in Infants With Mild Encephalopathy
Hypoxic-Ischemic Encephalopathy · Brain Injury · Neonatal Seizure
Primary: Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality. — 28 Participants
Phase 2 N=1,379 GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
Sepsis
Primary: Percentage of Participants With 28-Day All Cause Mortality — 26.9; 25.8; 31.3 Percentage of participants — p=0.329
N/A N=22 Piperacillin PK Analysis in Severe Sepsis Patients
Sepsis · Severe Sepsis
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 4 participants
N/A N=369 Defining the Intestinal Microbiota in Premature Neonates
Premature Intestinal Microbiota · Necrotizing Enterocolitis · Late Onset Bloodstream Infection
Primary: The Composition of Bacteria Present, Established by Ultra-deep RNA Gene Sequencing, in Pre-morbid Faecal Samples From Neonates With Necrotizing Enterocolitis and…