Clinical trials: Early-onset Neonatal Infection
Premature Rupture of Membrane, Neonatal Infection
Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns.
- Trial name
- NCT03251898
- Where
- 6 sites in China
- Volunteers
- 15,926 people, healthy volunteers welcome
- Sponsor
- Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
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
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
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations…
- 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
- PREPARE (NCT04653948)
- Where
- Uganda
- Volunteers
- 3,423 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Neonatal Early-onset Sepsis, Neonatal Late-onset Sepsis
A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences including development of necrotizing enterocolitis (a serious, potentially life-threatening gastrointestinal illness in premature…
- Trial name
- NCT01825421
- Testing
- Intervention is to stop antibiotics at 24h .
- Where
- United States
- Sponsor
- Yale University
Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)
The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel
Determination of GBS colonization rates in Pregnant Women insured with Maccabi Health Services, Doctors' Compliance Rates for Referral for Testing, test execution rates, and Early-onset GBS Disease (EOGBSD) Rates in Israel.
- Trial name
- NCT04222907
- Volunteers
- 54,759 people
- Sponsor
- Assuta Hospital Systems
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)
Sepsis
Neonatal Procalcitonin Intervention Study
In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values.
- Trial name
- NeoPInS (NCT00854932)
- Testing
- Procalcitonin-guided decision making
- Where
- Switzerland
- Volunteers
- 1,600 people
- Sponsor
- Luzerner Kantonsspital
Neonatal SEPSIS
The Role of Neutrophil CD64 and Soluble Triggering Receptor Expressed on Myeloid Cells 1 in Neonatal Sepsis
Neonatal sepsis (NS) is a rather serious but relatively common health problem. Despite recent advances in the treatment of neonatal infection, mortality and comorbidities remain high.
- Trial name
- NCT03795285
- Testing
- Expression of neutrophil CD64
- Volunteers
- 50 people
- Sponsor
- Assiut University
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
Chorioamnionitis, Early Onset Neonatal Sepsis
Chorioamnionitis: Observation of at Risk Infants vs Standard Care
This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood count, blood culture) and clinical observation by standardized physical examination versus the algorithm suggested in the CDC's 2010…
- Conditions
- Chorioamnionitis, Early Onset Neonatal Sepsis, Sepsis of the Newborn
- Trial name
- CHORIS-RCT (NCT02886910)
- Testing
- Clinical observation, Standard management
- Where
- Italy
- Sponsor
- IRCCS Burlo Garofolo
Preterm Infant, Early-Onset Neonatal Sepsis
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T…
- Conditions
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- Trial name
- NCT03694613
- Testing
- Placental/Umbilical Cord Blood sample
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- The University of Texas Medical Branch, Galveston
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
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
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
Neonatal Sepsis
Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study…
- Trial name
- NCT02959229
- Testing
- Lactoferrin
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
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
Neonate, Sepsis
Point of Care - Sepsis Study
This pilot study will evaluate whether a rapid point-of-care blood test can help identify early signs of infection and sepsis in preterm infants.
- Conditions
- Neonate, Sepsis, IL6, PCT
- Trial name
- POCT Sepsis (NCT07774013)
- Testing
- Point-of-Care Measurement of Inflammatory Biomarkers
- Where
- Austria
- Volunteers
- 80 people
- Sponsor
- Medical University of Graz
Neonatal Sepsis, Early-Onset, Culture Positive Neonatal Sepsis
Molecular Culture for the Diagnosis of Neonatal Sepsis
Rationale: Early diagnosis of sepsis in neonates is complicated as the signs and symptoms are nonspecific. Although blood culture is the gold standard for the diagnosis, false-negative results and long incubation period of 36-72…
- Conditions
- Neonatal Sepsis, Early-Onset, Culture Positive Neonatal Sepsis, Culture Negative Neonatal Sepsis, Clinical Sepsis
- Trial name
- NCT05763680
- Testing
- Molecular Culture
- Where
- Netherlands
- Volunteers
- 2,000 people
- Sponsor
- Jip Groen
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