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.
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=21 Inflammatory Cytokine Quantification in Infants
Sepsis · Congenital Diaphragmatic Hernia · Neonatal Cardiopulmonary Failure
Primary: TNF-alpha, Baseline — 8.88 pg/mL
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
Phase 3 N=46 Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
Herpes Simplex
Primary: Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment (Motor Scores). — 10; 5; 0; 1 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 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…
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
N/A N=500 Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
Chlamydia Trachomatis Infection · Neonatal Infection · Preterm Birth
Primary: Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery — 2; 23 Participants
Phase 4 N=11 Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
Pulmonary Infections
Primary: Percent Reduction in Oxygen Requirement From Baseline — 5.4; 16.5 percentage FiO2
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
Phase 1 N=32 Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Sepsis
Primary: Piperacillin Pharmacokinetics (PK) — 0.0799 L/hr/kg
Phase 2 N=46 Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Chorioamnionitis · Brain Injury
Primary: NAC Terminal Elimination Half-life — 1.2; 7.5; 5.1 hours
Phase 2 N=300 Infant TB Infection Prevention Study
Tuberculosis
Primary: Mycobacterium Tuberculosis (MTB) Infection — 10; 18 participants
Phase 1 N=44 Intestinal Permeability in Preterm Infants
Prematurity · Intestinal Permeability
Primary: Intestinal Permeability — 0.0731; 0.0720 ratio — p=0.932
N/A N=307 Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial
Staph Aureus Colonization · Staph Aureus Infection
Primary: Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain — 13; 29 neonatal S. aureus infections
Phase 4 N=52 Early Sodium Intake in Preterm Newborns
Hyponatremia · Premature
Primary: Hyponatremia — 6; 1 Participants — p=0.71
Phase 1 N=32 A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Herpes Simplex Virus · Neonatal Sepsis
Primary: Clearance (CL) — 0.278 L/h/kg
N/A N=50 Post-bypass Prophylactic IVIG in Infants and Neonates
Hypogammaglobulinemia · Congenital Heart Disease
Primary: Post-Operative Infections — 9; 6; 21; 14 subjects — p=1
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=97,507 Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Neonatal Death · Prematurity
Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants
Phase 2 N=48 Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Extremely Low Gestational Age Newborn · Premature Infant
Primary: Urinary Secretary IgA Concentration at 2 Weeks of Age — 233.8; 48.3 ng per g creatinine — p=0.006
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…
Phase 4 N=21,832 Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso
Childhood Mortality
Primary: 6 Month Mortality - All Cause — 42; 50 Participants
Phase 2 N=56 Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Complication Due to Immunization
Primary: The Change in the Number of CRE (Extracted From Printed Monitoring Tracings Compared to Noted Nurses' Surveillance) Following the First Dose of Pentavalent Vaccine in…
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
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
Phase 2 N=121 Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Ureaplasma Infections
Primary: Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma — 37; 55 Participants — p=<0.0001
N/A N=168 Preemie Hypothermia for Neonatal Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 29; 20 Participants
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