Clinical trials: Early-onset Neonatal Infection
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
Neonatal Sepsis
Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe
The goal of this observational study is to develop a risk prediction model for early-onset neonatal sepsis in term and late preterm neonates in Uganda and Zimbabwe.
- Trial name
- NeoRisk (NCT06411405)
- Testing
- Maternal medical history
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
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
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 Neonatal Sepsis
Antibiotic Therapy for Early Onset Neonatal Sepsis
Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line…
- Trial name
- NCT03932123
- Testing
- Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Shandong University
Newborn
Clinical Evaluation of Early Onset Neonatal Infection
Early bacterial neonatal infection (INBP) defined as occurring in the first 3 days and by extension in the first week of life, remains to this day the leading cause of neonatal morbidity and mortality in developed countries.
- Trial name
- CLEEONI (NCT04470596)
- Where
- France
- Volunteers
- 936 people
- Sponsor
- Fondation Hôpital Saint-Joseph
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
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 Neonatal Infection
Diagnostic Performance Comparison Between Procalcitonin-based vs. ANAES-based Guidelines
Neonatal bacterial infection remains a serious pathology in industrialized countries despite the use of prophylaxis measures for group B streptococcus (GBS) (peri-partum antibiotic in women with GBS colonization), which was…
- Trial name
- DIACORD (NCT02590198)
- Testing
- ANAES algorithm, PCT algorithm
- Where
- 14 sites in France
- Volunteers
- 9,201 people
- Sponsor
- Nantes University Hospital
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
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
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
Neonatal Early-onset Sepsis
Cahnge in Management of Suspected Early Onset Neonetal Sepsis After Assimilation of Early Onset Sepsis Calculator
Early neonatal sepsis requires rapid and efficient intervention to prevent morbidity and mortality. Management of such a case includes invasive blood examinations, elongation of maternal and neonatal length of stay, and empiric…
- Trial name
- NCT06643052
- Testing
- No intervention
- Where
- Israel
- Volunteers
- 6,300 people
- Sponsor
- Hillel Yaffe Medical Center
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 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
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
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
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis
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
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)