Clinical trials: Early Onset Sepsis
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
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
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, 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
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
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
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
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
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 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
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
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
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
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
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
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
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
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 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 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