Clinical trials: Newborn Sepsis
Feeding; Difficult, Newborn, Growth Failure
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections.
- Conditions
- Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis
- Trial name
- PROPEL (NCT01603368)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Sweden
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ostergotland County Council, Sweden
Sepsis
Zambia Chlorhexidine Application Trial
This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry…
- Trial name
- ZamCAT (NCT01241318)
- Testing
- Chlorhexidine gluconate (4%), Dry cord care
- Where
- Zambia
- Volunteers
- 77,535 people, healthy volunteers welcome
- Sponsor
- Boston University
Neonatal Sepsis
Salivary C- Reactive Protein, Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis
To evaluate reliability of salivary C-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis
- Trial name
- NCT04800445
- Testing
- Salivary CRP
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Cairo University
Neonatal SEPSIS
Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
Sepsis has its greatest impact in the prematurely born (preterm) population. Neonatal sepsis (sepsis within the first month of life) causes over one million deaths worldwide annually, and is one of the most common, difficult and…
- Trial name
- NCT03291496
- Testing
- Blood Collection Preterm, Blood Collection Term, Adult Blood collection
- Where
- United States
- Volunteers
- 293 people, healthy volunteers welcome
- Sponsor
- University of Florida
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
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
Bacteremia, Infant, Very Low Birth Weight
Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants.
- Trial name
- MultilineNEO (NCT02633124)
- Testing
- Edelvaiss Multiline NEO, Standard Infusion Set
- Where
- 4 sites in France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Neonatal Sepsis
Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.
- Trial name
- NCT01479114
- Testing
- rh-GCSF
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Neonatal SEPSIS, Nosocomially Acquired Neonatal Sepsis
A Study on Ventilator-associated Pneumonia as a Risk for Nosocomial Infection in Mechanically Ventilated Neonates In NICU of Assiut University Children Hospital (Nicu Eta)
Abstract Background: Neonatal ventilator associated pneumonia (VAP) is a major hospital-acquired infection in acute care settings, associated with high mortality and poor outcome.
- Trial name
- nicu eta (NCT03310840)
- Testing
- others
- Where
- Egypt
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Assiut University
Sepsis
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates.
- Trial name
- NCT00518596
- Testing
- Probiotic supplementation (Lactobacillus plantarum)
- Where
- 3 sites in India
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Neonatal Sepsis, Markers
Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis
1. To assess myocardial function in neonates with sepsis using tissue doppler echocardiography. 2. To assess sepsis induced cardiac dysfunction. 3.
- Trial name
- NCT07572916
- Testing
- cardiac troponin, and blood culture
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Assiut University
Congenital Heart Disease, Viremia
Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes
Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certainly no comprehensive study…
- Conditions
- Congenital Heart Disease, Viremia, Virus Diseases, Enterovirus
- Trial name
- CHARMED (NCT04769167)
- Testing
- Stool and Blood Specimen Collection, Follow-up Medical Record Review
- Where
- 2 sites in United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Prematurity, Neonatal Sepsis
Defects in Opsonophagocytosis in Premature Infants
The purpose of the study is to characterize innate immune function of premature infants, and identify defects that may be responsible for the development of bacterial sepsis.
- Trial name
- NCT00866567
- Where
- Switzerland
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Maternal Death, Maternal Infections Affecting Fetus or Newborn
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.
- Conditions
- Maternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor
- Trial name
- NCT03871491
- Testing
- Azithromycin
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 58,747 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Preterm, Patent Ductus Arteriosus
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates.
- Conditions
- Preterm, Patent Ductus Arteriosus, Sepsis, Asphyxia
- Trial name
- CE-NeoDoppler (NCT06646250)
- Testing
- NeoDoppler - CE certified
- Where
- Norway
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- St. Olavs Hospital
Pulmonary Disease, Electrolyte Disorder
Comparison of Success Rates of Femoral Artery Catheterization
The use of USI has eased practical application of interventional procedures, and reduced complications and procedure durations. For vascular interventions with ultrasound imaging, short- or long-section imaging of vascular…
- Conditions
- Pulmonary Disease, Electrolyte Disorder, Metabolic Disease, Sepsis
- Trial name
- NCT02986542
- Testing
- Femoral artery catheterization
- Where
- Turkey (Türkiye)
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Neonatal Sepsis, Sepsis
Probiotics for Prevention Neonatal Infection
Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world.
- Conditions
- Neonatal Sepsis, Sepsis, Neonatal Infections
- Trial name
- NCT01214473
- Testing
- Synbiotics, Maltodextrin
- Where
- 2 sites in India
- Volunteers
- 4,556 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
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 SEPSIS
Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death
Though maternal and neonatal health are high priority areas for international development, maternal and neonatal mortality remain unacceptably high.
- Trial name
- PregnAnZI-2 (NCT03199547)
- Testing
- Azithromycin
- Where
- 2 sites in Burkina Faso, The Gambia
- Volunteers
- 11,985 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Gastric Residuals Assessment, Prematurity
Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?
The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications…
- Conditions
- Gastric Residuals Assessment, Prematurity, Sepsis Newborn, Necrotizing Enterocolitis of Newborn
- Trial name
- GRASS (NCT03111329)
- Testing
- No aspiration of gastric residuals
- Where
- 2 sites in Czechia, Ireland
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic