Clinical trials: Neonatal Sepsis, open to volunteers
Sepsis, Sepsis Bacterial
Molecular Culture for the Diagnosis of Pediatric Sepsis
Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the…
- Conditions
- Sepsis, Sepsis Bacterial, Sepsis, Neonatal, Infection, Bacterial
- Trial name
- CHAMPIONS (NCT06018792)
- Testing
- Molecular Culture
- Where
- 2 sites in Netherlands
- Volunteers
- 1,835 people
- Sponsor
- Jip Groen
Neonatal Late Onset Sepsis
Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).
- Trial name
- RUBIS (NCT06058819)
- Testing
- Newborns suspected of Infections
- Where
- 3 sites in France
- Volunteers
- 285 people
- Sponsor
- Hospices Civils de Lyon
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Neonatal Sepsis, Neutropenia
G-CSF In Neonatal Sepsis With Neutropenia
This study will evaluate whether adding G-CSF to standard treatment improves outcomes in newborns (0-28 days) with sepsis and neutropenia.
- Trial name
- NCT07888829
- Testing
- Granulocyte-colony stimulating factor (G-CSF), Standard Sepsis Management
- Where
- Pakistan
- Volunteers
- 52 people
- Sponsor
- University of Health Sciences Lahore
Chronic Granulomatous Disease, Infection
NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
Background: CGD is caused by a gene mutation. For people with CGD, their cells cannot kill germs well, so they can get frequent or life-threatening infections.
- Trial name
- NCT05189925
- Testing
- gp91 Grans
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Neurological Menfestions in Neonatal Sepsis
Detection of Neurological Manifestations Among Neonates With Sepsis
This observational prospective study aims to detect neurological menifestations in neonates with sepsis attending Assiut University Children Hospital
- Trial name
- NCT07813689
- Volunteers
- 100 people
- Sponsor
- Assiut University
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
The main objective of the Phase 2 part of the trial is to assess the immunogenicity of GBS-NN/NN2 vaccine at birth in infant participants and to determine the occurrence of serious adverse events (SAEs) and adverse event of…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- MOTIVATION (NCT07922226)
- Testing
- GBS-NN/NN2 vaccine
- Volunteers
- 6,600 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Sepsis, Newborn Sepsis
T6A Biomarker for Detection of Bacterial Infection in Newborn Infants
This bi-center study aims to assess the efficacy of a new biomarker, N6-threonylcarbamoyladenosine (t6A), for the early diagnosis of Early-Onset Sepsis (EOS) in newborns.
- Conditions
- Sepsis, Newborn Sepsis, Biomarker Discovery
- Trial name
- T6ASepsis (NCT07670624)
- Where
- 2 sites in Austria, Poland
- Volunteers
- 210 people
- Sponsor
- Salzburger Landeskliniken
Neonatal Sepsis, Sepsis
CBC Indices and Serum Lactate in Neonatal Sepsis
Neonatal sepsis is a leading cause of illness and death in Neonatal Intensive Care Units (NICUs). Diagnosing it quickly is challenging because the early signs often overlap with other common newborn health issues.
- Trial name
- NCT07663084
- Volunteers
- 80 people
- Sponsor
- Assiut University
Peripherally Inserted Central Catheter, Umbilical Venous Catheter
Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"
This study aims to prospectively compare umbilical venous catheters (UVCs) and peripherally inserted central catheters (PICCs) in neonates, focusing on complications, catheter survival, and central line-associated bloodstream…
- Conditions
- Peripherally Inserted Central Catheter, Umbilical Venous Catheter, CLABSI - Central Line Associated Bloodstream Infection
- Trial name
- NCT07209670
- Testing
- peripherally inserted central catheter insertion, umbilical venous catheters insertion
- Volunteers
- 360 people
- Sponsor
- Assiut University
Neonatal Sepsis
Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection
This study aims to compare of effect of chlorhexidine gluconate and alcohol hand rubbing on healthcare-associated infection (HCAI) in neonatal intensive care unit at Alexandria University Children Hospital.
- Trial name
- NCT07421323
- Testing
- Alcohol hand rub group, Chlorhexidine hand rub
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University
Autoimmune Diseases, Lupus Erythematosus, Systemic
Comparative Autoantibody and Immunologic Cell Marker Study
The purpose of this study is to compare immune phenotype, function, and specificity of B lymphocytes from different developmental stages in autoimmune patients to B cells from infectious disease patients and healthy controls.
- Conditions
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Communicable Diseases
- Trial name
- NCT02422875
- Where
- 3 sites in United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Emory University
Early-onset Sepsis
Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis
In this study, three neonatal evidence-based antibiotic stewardship strategies will be implemented in Dutch hospitals. These include the early-onset sepsis (EOS) calculator, procalcitonin (PCT)-guided therapy, and IV-to-oral…
- Trial name
- PrOTeCt-NEO (NCT06845332)
- Where
- 11 sites in Netherlands
- Volunteers
- 55,000 people
- Sponsor
- Franciscus Gasthuis
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
Neonatal Catheter Lock for Infection Prevention
For newborns admitted to Neonatal Intensive Care Units (NICUs), one of the main risk factors for late-onset sepsis is the presence of a central venous catheter (CVC), which is often essential for the administration of medications…
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Neonatal Sepsis, Late-Onset
- Trial name
- Neo-CLIP (NCT07585188)
- Testing
- Taurolidine 2% lock, Normal saline lock
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- University of Turin, Italy
Antibiotic Stewardship, Neonatal Sepsis, Late-Onset
Vancomycin Reduction Practices (VRP) in the NICU
This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs).
- Conditions
- Antibiotic Stewardship, Neonatal Sepsis, Late-Onset, Vancomycin
- Trial name
- NCT06772675
- Testing
- External Facilitation
- Where
- 13 sites in United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
Rupture of Membranes Prior to Onset of Labor
PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
The goal of this clinical trial is to learn whether adding gentamicin to standard ampicillin prophylaxis can better prevent clinical chorioamnionitis and other maternal and neonatal infectious complications in pregnant women aged…
- Trial name
- PROMab (NCT07563504)
- Testing
- Ampicillin, Ampicillin + gentamicin
- Where
- 3 sites in Malaysia
- Volunteers
- 320 people
- Sponsor
- Sarawak General Hospital
Neonatal Sepsis, Markers
Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis
1. To assess myocardial function in neonates with sepsis using tissue doppler echocardiography. 2. To assess sepsis induced cardiac dysfunction. 3.
- Trial name
- NCT07572916
- Testing
- cardiac troponin, and blood culture
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Assiut University
Prematurity, Infections, NIRS
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early…
- Conditions
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates
- Trial name
- POP-Score (NCT07109856)
- Testing
- POP-Score Assessment, Near-Infrared Spectroscopy (NIRS)
- Where
- Austria
- Volunteers
- 93 people
- Sponsor
- Medical University of Graz
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Amniotic Fluid & the Preterm Gut
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations.
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset
- Trial name
- AMFIBIE (NCT07152106)
- Where
- 2 sites in Netherlands
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Sepsis, PROM, Preterm (Pregnancy)
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth.
- Conditions
- Sepsis, PROM, Preterm (Pregnancy), Early-Onset Neonatal Sepsis, Preterm Premature Rupture of Membrane
- Trial name
- SAUNA (NCT06377397)
- Testing
- Antibiotics
- Where
- 9 sites in India
- Volunteers
- 1,500 people
- Sponsor
- Indian Council of Medical Research