Clinical trials: Early Onset Sepsis
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
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
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
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Neonatal SEPSIS
Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis
1. Evaluate the relationship of RDW and severity and mortality in patients with neonatal sepsis . 2. Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of neonatal sepsis .
- Trial name
- NCT03403062
- Volunteers
- 100 people
- Sponsor
- Assiut University
Premature Rupture of Membrane
Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes
The objective of the study is to compare a new antibiotic protocol with the current prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm labor, chorioamnionitis and early onset sepsis
- Trial name
- NCT02819570
- Testing
- I.V cefuroxime 750 mg*3/d for 2 days, I.V ampicillin 2 gram x4/d for 2 days, P.O cefuroxime 500 mgx2/d for 5 days
- Where
- Israel
- Volunteers
- 400 people
- Sponsor
- Western Galilee Hospital-Nahariya
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
PPROM, Early-Onset Neonatal Sepsis
Predicting EONS in PPROM Patients
An EONS occurred in nearly 14-22 % of the preterm infant of pregnant women with PPROM. To this day no risk prediction is established.
- Trial name
- PEONS (NCT03819192)
- Testing
- microbiome analysis, Conventional cultures, CAAP48 measurement
- Where
- 2 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Jena University Hospital
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
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
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
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)
Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome
Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes
The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high…
- Conditions
- Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome, Early Onset Neonatal Sepsis, Infection of Amniotic Cavity
- Trial name
- MuMFI-PPROM (NCT02702297)
- Testing
- single arm
- Where
- 4 sites in Germany
- Volunteers
- 57 people
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg
Neonatal Sepsis, Early-Onset
Performance of Interleukin-27 Cord Blood Level as A Biomarker Predicating Early Onset Neonatal Sepsis
Neonatal sepsis still considered as one of the major causes of mortality and morbidity during the neonatal period due to high vulnerability of that age group.
- Trial name
- NCT05589909
- Testing
- IL27, PCT, CRP, Blood culture
- Where
- United Arab Emirates
- Volunteers
- 548 people
- Sponsor
- Mansoura University Children Hospital
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
Maternal; Chorioamnionitis, Affecting Fetus, Early-Onset Sepses, Neonatal
A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University…
- Trial name
- NCT04513691
- Testing
- EOS Calculator
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Pediatrix
Early-Onset Neonatal Sepsis, Antibiotic Side Effect
Individualized Duration of Antibiotic Treatment in Early Onset Infection in Newborns.
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment…
- Trial name
- DurATi-n (NCT05329701)
- Testing
- Individualized treatment duration strategy
- Where
- Denmark
- Volunteers
- 488 people
- Sponsor
- Ulrikka Nygaard
Neonatal Sepsis
Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis
124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and ELISA estimation of serum levels of PSP…
- Trial name
- NCT05022043
- Testing
- Serum Presepsin
- Where
- Egypt
- Volunteers
- 124 people
- Sponsor
- Tanta University
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
Early-Onset Neonatal Sepsis
PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis…
- Trial name
- PROPOSE (NCT05796115)
- Testing
- Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS, Antibiotic prophylaxis for EOS
- Volunteers
- 266 people
- Sponsor
- University of Florence