Clinical trials: Sepsis, Neonatal
Early-Onset Neonatal Sepsis
Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations
The purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin/tazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic…
- Trial name
- NCT06076200
- Testing
- Piperacillin Sodium and Tazobactam Sodium for Injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shandong University
Early Onset Sepsis
Extended Interval Dosing of Gentamicin in Neonates
A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old.
- Trial name
- NCT07460349
- Testing
- Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours, Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Infection Associated With Catheter, Bacteremia
Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates
Appropriate delivery of adequate nutrition and medications in premature infants often requires central venous access in the form of a special IV called a PICC (peripherally inserted central catheter).
- Conditions
- Infection Associated With Catheter, Bacteremia, Sepsis
- Trial name
- NCT01365312
- Testing
- Ethanol lock, Heparinized saline
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- East Carolina University
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
Hypoxemia, Neonatal Disease
Evaluation of a Multi-country Medical Oxygen Program
REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for…
- Conditions
- Hypoxemia, Neonatal Disease, Pneumonia, Sepsis
- Trial name
- REAL-MOXY (NCT06087315)
- Testing
- Multi-faceted oxygen systems strengthening interventions (different for each country)
- Where
- 3 sites in Cambodia, Nigeria and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Murdoch Childrens Research Institute
Neonatal Sepsis
Distribution of Haptoglobin Phenotype in Septic and Non Septic Pre-term Neonates (PTSH)
The Haptoglobin (Hp) gene locus at chromosome 16q22 is polymorphic with two alleles denoted 1 and 2 .The gene product exists in three phenotypes: 1-1, 2-1, and 2-2.
- Trial name
- NCT00800449
- Where
- Israel
- Volunteers
- 133 people
- Sponsor
- Irina Kessel
Sepsis Newborn, Infection
Glove-based Care in the NICU to Prevent Late Onset Sepsis
Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is not related to their delivery but to the hospital environment.
- Trial name
- GloveCare (NCT03078335)
- Testing
- Glove based care, Standard of Care - Hand Hygiene
- Where
- Canada
- Volunteers
- 786 people, healthy volunteers welcome
- Sponsor
- Hamilton Health Sciences Corporation
Early-Onset Sepsis, Neonatal, EOS
Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator
Newborns are at risk for early-onset sepsis (EOS), which occurs within 72 hours after birth. The incidence of proven EOS is 0.5-2.0 per 1000 live births.
- Trial name
- NCT05274776
- Testing
- EOS calculator
- Where
- 10 sites in Netherlands
- Volunteers
- 1,830 people
- Sponsor
- prof. dr. Frans B. Plötz
Neonatal SEPSIS
Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital
Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.
- Trial name
- NCT03354650
- Testing
- blood culture
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Assiut University
Neonatal SEPSIS
NeoAMR Observational Study in Neonatal Sepsis
Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess…
- Trial name
- NCT03721302
- Testing
- Main study clinical sepsis, Microbiology sub study
- Where
- 19 sites in Bangladesh, Brazil and 9 more
- Volunteers
- 3,202 people
- Sponsor
- Drugs for Neglected Diseases
Neonatal Sepsis
Potential Protective Effect of a Formula Supplemented With Fermented Matrices on the Risk of Developing Neonatal Sepsis
This is a multicenter, randomized, double-blind, placebo controlled trial, with parallel groups and reference group. The aim of the study was to evaluate the hypothesis that an immunonutritional strategy, based on use of…
- Trial name
- NCT04742582
- Testing
- Preterm Infants - fed fermented formula, Preterm Infants - fed standard formula, Pre-term Infants - breastfed
- Where
- Italy
- Volunteers
- 876 people
- Sponsor
- Heinz Italia SpA
Sepsis
Neonatal Sepsis, Evaluation, Bangladesh
More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis).
- Trial name
- NCT01333982
- Testing
- Amoxycillin, Gentamicin, Counselling
- Where
- Bangladesh
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
EBV Viremia, CMV Viremia
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
This study is evaluating the safety and effectiveness of virus-specific cytotoxic T lymphocytes (vCTLs) for treating difficult-to-control viral infections caused by cytomegalovirus (CMV), adenovirus (ADV), Epstein-Barr virus…
- Conditions
- EBV Viremia, CMV Viremia, BK Viremia, Adenovirus
- Trial name
- NCT07873970
- Testing
- Virus-Specific Cytotoxic T Lymphocytes (vCTLs)
- Volunteers
- 35 people
- Sponsor
- Children's Hospital of Philadelphia
Microbial Colonization, Tolerance
SEPSIS: L. Plantarum Trial
Sepsis is a life-threatening clinical syndrome and a leading cause of neonatal deaths worldwide. The burden of neonatal sepsis and severe infection (SI) is particularly high in areas of South Asia and other resource-limited…
- Conditions
- Microbial Colonization, Tolerance, Safety Issues, Infant ALL
- Trial name
- NCT05180201
- Testing
- Synbiotic, Probiotic
- Where
- 2 sites in Bangladesh
- Volunteers
- 519 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Neonatal Sepsis
The Volume of Blood Submitted for Culture in Neonates - a Multicentre Quality Improvement Initiative.
The study will examine if introducing the practice of checking the volume of blood culture samples in neonates by bedside weighing will improve the sensitivity of the test and increase confidence in negative results affecting the…
- Trial name
- VOB4C (NCT04455022)
- Testing
- Bedside blood culture bottles weighing combined with educational interventions.
- Where
- 4 sites in Poland
- Volunteers
- 600 people
- Sponsor
- Medical University of Warsaw
Hypoxic-Ischemic Encephalopathy, Sepsis
Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants
Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Sepsis, Kidney Diseases, Metabolic Disease
- Trial name
- NCT05495607
- Testing
- CARPEDIEN
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care
SEPREVEN: a Stepped-wedge Randomised Controlled Trial
Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator…
- Conditions
- Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care, Catheter-related Bloodstream Infection (CRBSI) Nos, Quality of Healthcare
- Trial name
- SEPREVEN (NCT02598609)
- Testing
- Education program for NICU caregivers
- Where
- 12 sites in France
- Volunteers
- 8,000 people
- Sponsor
- Dr Caeymaex Laurence
Neonatal Mortality, Neonatal Sepsis
Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
Each year four million babies die during the neonatal period, with the majority occurring in developing countries. Overall, infections account for one-third of all neonatal deaths, with proportions approaching 50% in settings…
- Trial name
- NOMS (NCT01177111)
- Testing
- Sunflower seed oil, Mustard seed oil
- Where
- Nepal
- Volunteers
- 29,260 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Neonatal Sepsis
Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis
The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic…
- Trial name
- suPAR (NCT01294865)
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ankara University
Central Line Bloodstream Infections
The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants
The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.
- Trial name
- NCT00964093
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute