Clinical trials: Neonatal SEPSIS
Umbilical Cord Infection, Umbilical Sepsis
Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)
The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates.
- Conditions
- Umbilical Cord Infection, Umbilical Sepsis, Neonatal Sepsis
- Trial name
- NCT05569551
- Testing
- Adhesive pouch
- Where
- Malaysia
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- AIMST University Malaysia
Hypothermia
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization.
- Trial name
- NCT00904228
- Testing
- placement of plastic cap during delivery room stabilization, placement of routine cap during delivery room stabilization
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Vascular Access Complication, Hemodialysis Access Failure
Optimizing Access Surgery In Senior Hemodialysis Patients
The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients.
- Conditions
- Vascular Access Complication, Hemodialysis Access Failure, Dialysis Access Malfunction, Arteriovenous Fistula
- Trial name
- OASIS (NCT05911451)
- Testing
- Arteriovenous fistula creation, Arteriovenous graft placement, Central venous catheter placement
- Where
- 20 sites in Netherlands
- Volunteers
- 166 people
- Sponsor
- Maastricht University Medical Center
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 Sepsis
Extended Interval Dosing of Gentamicin in Neonates
A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old.
- Trial name
- NCT07460349
- Testing
- Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours, Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Neonatal Sepsis, Omphalitis
A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns
Introduction: Neonatal sepsis in one of the leading cause of death in developing countries. Umbilical cord care is important as it may lead to infection.
- Trial name
- NCT06002295
- Testing
- Chlorhexidine Topical Cream, Methylated Spirit
- Where
- Pakistan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
Infant, Premature
Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic.
- Trial name
- Digi-NewB (NCT02863978)
- Testing
- Multimodal signal acquisitions
- Where
- 6 sites in France
- Volunteers
- 746 people
- Sponsor
- Rennes University Hospital
Neonatal Staphylococcal Sepsis
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S.
- Trial name
- N002 (NCT00631878)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Biosynexus Incorporated
Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care
SEPREVEN: a Stepped-wedge Randomised Controlled Trial
Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator…
- Conditions
- Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care, Catheter-related Bloodstream Infection (CRBSI) Nos, Quality of Healthcare
- Trial name
- SEPREVEN (NCT02598609)
- Testing
- Education program for NICU caregivers
- Where
- 12 sites in France
- Volunteers
- 8,000 people
- Sponsor
- Dr Caeymaex Laurence
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
Sepsis
Prevention of Infection in Indian Neonates - Phase I Observational Study
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates.
- Trial name
- NCT00518609
- Where
- 3 sites in India
- Volunteers
- 1,326 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
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
Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)
This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.
- Trial name
- NCT02567305
- Testing
- Markers of NET formation
- Where
- 2 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
EBV Viremia, CMV Viremia
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
This study is evaluating the safety and effectiveness of virus-specific cytotoxic T lymphocytes (vCTLs) for treating difficult-to-control viral infections caused by cytomegalovirus (CMV), adenovirus (ADV), Epstein-Barr virus…
- Conditions
- EBV Viremia, CMV Viremia, BK Viremia, Adenovirus
- Trial name
- NCT07873970
- Testing
- Virus-Specific Cytotoxic T Lymphocytes (vCTLs)
- Volunteers
- 35 people
- Sponsor
- Children's Hospital of Philadelphia
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
Bacillus Cereus Infection
Contamination of Bacillus Species Sepsis.
Bacillus species are ubiquitous gram-positive spore-forming organisms. They rarely cause disease in the immunocompetent and are more frequently isolated as a culture contaminant.
- Trial name
- BACILLUS (NCT03377530)
- Testing
- Ways to prevent these infections.
- Where
- France
- Volunteers
- 11 people
- Sponsor
- Hôpital NOVO
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
Catheter-related Bloodstream Infection, Preterm
Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
Epicutaneo-caval catheters (ECCs) are widely used in neonatal intensive care units (NICUs). They are small catheters inserted via superficial veins of the limbs or scalp using direct vein visualization The pathogenic…
- Conditions
- Catheter-related Bloodstream Infection, Preterm, Catheter Infection, Catheter Complications
- Trial name
- LOOSEN (NCT05729321)
- Testing
- neutrox
- Where
- 2 sites in Italy
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS