Clinical trials: Neonatal Early-onset Sepsis
Neonatal Sepsis
Neonatal Sepsis and GBS Carriage Study
In the proposed study, the investigators plan to establish the burden of early onset (EO) neonatal sepsis in the newborn population born at Maela Refugee Camp over a two year period. Aims 1.
- Trial name
- NSS (NCT00861055)
- Where
- Thailand
- Volunteers
- 849 people
- Sponsor
- University of Oxford
Early-Onset Neonatal Sepsis
Presepsin to Safely Reduce Antibiotics in Preterm Infants
In the Netherlands, more than 85% of the preterm infants born <32 weeks gestational age get antibiotics directly after birth because of the risk of infection with a bacteria.
- Trial name
- PRESAFE (NCT06100614)
- Testing
- Presepsin, Standard Care
- Where
- Netherlands
- Volunteers
- 900 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Chorioamnionitis, Puerperal Endometritis
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal…
- Conditions
- Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis
- Trial name
- NCT01633294
- Testing
- Ampicillin + gentamicin
- Where
- Portugal
- Volunteers
- 161 people
- Sponsor
- Hospital de Santa Maria, Portugal
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
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
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to…
- Trial name
- NCT02061150
- Where
- Israel
- Volunteers
- 800 people
- Sponsor
- Hillel Yaffe Medical Center
Early Onset Neonatal Sepsis
Management of Early Onset Neonatal Septicaemia: Selection of Optimal Antibacterial Regimen for Empiric Treatment
A prospective two-center antibiotic regimen switch study will be conducted to compare the clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus ampicillin/gentamicin - in the empirical treatment of early…
- Trial name
- NCT00487019
- Where
- 2 sites in Estonia
- Volunteers
- 281 people
- Sponsor
- University of Tartu
Nosocomial Infection
New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn
This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.
- Trial name
- NOSODIAG (NCT00701948)
- Where
- 2 sites in France
- Volunteers
- 240 people
- Sponsor
- University Hospital, Strasbourg, France
Infant, Newborn, Infant, Low Birth Weight
Early-Onset Sepsis Surveillance Study
In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EOS (NCT00874367)
- Where
- 19 sites in United States
- Volunteers
- 615 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Diseases, Early Onset Neonatal Sepsis
Early-Onset Sepsis an NICHD/CDC Surveillance Study
This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms…
- Conditions
- Infant, Newborn, Diseases, Early Onset Neonatal Sepsis, Early-Onset Meningitis
- Trial name
- EOSII (NCT02410486)
- Where
- 20 sites in United States
- Volunteers
- 570 people
- Sponsor
- NICHD Neonatal Research Network
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
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
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period.
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- ProGreSs (NCT04549220)
- Where
- Uganda
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Sepsis
Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.
- Trial name
- NCT00926497
- Testing
- Procalcitonin-guided decision making
- Where
- Switzerland
- Volunteers
- 121 people
- Sponsor
- Luzerner Kantonsspital
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
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
Vitamin D Deficiency
Comparison of Maternal and Neonatal Vitamin D Levels in Term Neonates With and Without Early Onset Sepsis
Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life which is still an important cause of morbidity and mortality.
- Trial name
- NCT02019836
- Testing
- Determining maternal and neonatal vitamin D levels
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serocorrelate of Protection Against GBS (PREPARE WP3)
A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- NCT04732026
- Where
- 6 sites in France, Italy and 4 more
- Volunteers
- 600 people
- Sponsor
- St George's, University of London
Adenovirus, Anesthesia
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved.
- Conditions
- Adenovirus, Anesthesia, Anxiety, Anxiolysis
- Trial name
- PTN_POPS (NCT01431326)
- Testing
- The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 3,520 people
- Sponsor
- Daniel Benjamin
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