Clinical trials: Sepses, Neonatal
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
Neonatal Herpes Simplex Infection, Neonatal HSV Infection
Host RNA Expression Profiles and Protein Biomarkers in Neonatal Herpes Simplex Virus Infection
This study seeks to identify and test host RNA expression profiles in context to protein biomarkers in dried blood spot samples as novel diagnostic markers of neonatal herpes simplex virus infection and to improve the…
- Conditions
- Neonatal Herpes Simplex Infection, Neonatal HSV Infection, Neonatal Infection, Newborn; Infection
- Trial name
- NCT05226949
- Where
- 2 sites in Denmark
- Volunteers
- 159 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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, Pre-Term
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)
The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset…
- Conditions
- Sepsis, Pre-Term, Late-Onset Neonatal Sepsis
- Trial name
- OMEPS (NCT04717037)
- Testing
- Olive Oil Massage
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 300 people
- Sponsor
- King Abdullah International Medical Research Center
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
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait
Sepsis Newborn, Sepsis
A Multi-center Quasi-experimental Study in Northern Italy to Evaluate the Impact of Sepsis Bundle in Obstetric Settings: the SOS Study
Despite advances in the diagnosis and treatment of sepsis, the studies available in the literature report very high maternal and fetal/neonatal mortality and morbidity in cases of sepsis occurring during pregnancy or the…
- Trial name
- NCT07375108
- Testing
- microbiological results from blood cultures or other materials.
- Where
- Italy
- Volunteers
- 52 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Preterm Infant, Neonatal SEPSIS
Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection
The protective effect of mother's milk and colostrum on oropharyngeal cavity is not achievable with gavage feeding. This may be increase the risk of colonization of the oropharyngeal cavity with pathogenic bacteria and subsequent…
- Conditions
- Preterm Infant, Neonatal SEPSIS, Neonatal Feeding Disorder
- Trial name
- OPAMM (NCT03513146)
- Testing
- Oropharyngeal Administration of Mother's Milk (OPAMM)
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Mansoura University Children Hospital
Neonatal Sepsis
Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
The purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and…
- Trial name
- NCT01120678
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- University of Virginia
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)
Bacterial Infection, Sepsis
Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth.
- Conditions
- Bacterial Infection, Sepsis, Infant, Newborn
- Trial name
- NCT00189384
- Testing
- ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin
- Where
- Pakistan
- Volunteers
- 426 people
- Sponsor
- Aga Khan University
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Late Onset Neonatal Sepsis
MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates
This study aims to evaluate the diagnostic accuracy of monocyte distribution width (MDW) as a novel biomarker for late-onset neonatal sepsis in preterm neonates and to assess its association with disease severity and short-term…
- Trial name
- NCT07821190
- Testing
- MDW measurement
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Tanta University
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
Late-Onset Neonatal Sepsis
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no…
- Trial name
- NCT04842786
- Testing
- Coconut oil
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Neonatal Sepsis, Sepsis
Simplified Antibiotic Therapy for Sepsis in Young Infants
This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by…
- Conditions
- Neonatal Sepsis, Sepsis, Infection
- Trial name
- SATT (NCT01027429)
- Testing
- procaine penicillin and gentamicin, amoxicillin and gentamicin, procaine penicillin, gentamicin, amoxicillin
- Where
- Pakistan
- Volunteers
- 2,543 people
- Sponsor
- Aga Khan University
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas
Preterm Membrane Rupture, Neonatal Sepsis
Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes
There is no consensus around the world on the treatment of preterm rupture of membranes, which is one of the important causes of early neonatal sepsis and one of the common causes of prematurity.
- Trial name
- NCT04528251
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Mortality
Lufwanyama Neonatal Survival Project
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify…
- Trial name
- LUNESP (NCT00518856)
- Testing
- Neonatal resuscitation protocol, Standard of care
- Volunteers
- 3,559 people, healthy volunteers welcome
- Sponsor
- Boston University