Clinical trials: Newborn Sepsis
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Sepsis Newborn, Infection
Glove-based Care in the NICU to Prevent Late Onset Sepsis
Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is not related to their delivery but to the hospital environment.
- Trial name
- GloveCare (NCT03078335)
- Testing
- Glove based care, Standard of Care - Hand Hygiene
- Where
- Canada
- Volunteers
- 786 people, healthy volunteers welcome
- Sponsor
- Hamilton Health Sciences Corporation
Nosocomial Neonatal Sepsis
Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by…
- Trial name
- NCT01867138
- Testing
- Cefazolin, Vancomycin, Amikacin
- Where
- Argentina
- Volunteers
- 109 people
- Sponsor
- Hospital Italiano de Buenos Aires
Gastroesophageal Reflux, Presumed Sepsis
Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
The purpose of this research is to address the comparative effectiveness and harm of the therapeutics frequently given to pregnant women and their young infants including antibiotics, tocolytic agents, non-steroidal…
- Conditions
- Gastroesophageal Reflux, Presumed Sepsis, Patent Ductus Arteriosus, Chronic Lung Disease
- Trial name
- NCT01028183
- Where
- United States
- Sponsor
- Duke University
Newborn; Infection, Newborn Sepsis
New Protocol for Febrile Neonate Management
The objective of present study was to evaluate clinical and laboratory characteristics of febrile neonate and describe the incidence of SBI in febrile neonates.
- Trial name
- NCT03183531
- Testing
- C reactive protein
- Where
- Turkey (Türkiye)
- Volunteers
- 328 people
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Neonatal Sepsis
Frequency and Severity of Thrombocytopenia in Neonatal Sepsis
The aim of our study was to find the frequency of thrombocytopenia and its severity in neonates with sepsis
- Trial name
- NCT05692128
- Testing
- Hematological and chemistry tests
- Volunteers
- 50 people
- Sponsor
- Assiut University
Premature Intestinal Microbiota, Necrotizing Enterocolitis
Defining the Intestinal Microbiota in Premature Neonates
The investigators will collect daily faecal samples from premature (<32 weeks) infants in the intensive care unit from the day of birth until they are discharged.
- Conditions
- Premature Intestinal Microbiota, Necrotizing Enterocolitis, Late Onset Bloodstream Infection
- Trial name
- NCT01102738
- Where
- 3 sites in United Kingdom
- Volunteers
- 369 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Shock, Sepsis
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
The purpose of this study is To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI, GEF) and lung water…
- Conditions
- Shock, Sepsis, Systemic Inflammatory Response Syndrome, Low Cardiac Output
- Trial name
- PreloaDren (NCT01157299)
- Where
- 7 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitario La Paz
Infant, Premature, Hypoperfusion in Newborn
Monitoring of Systemic or Organ Perfusion for Preterm Infants
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants.
- Conditions
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn
- Trial name
- NCT03136172
- Testing
- NIRS (near Infra-red spectroscopy)
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Inha University Hospital
Sepsis
Impact of Heart Rate Characteristics Monitoring in Neonates
Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.
- Trial name
- HeRO (NCT00307333)
- Testing
- HeRO heart rate characteristics monitor
- Where
- 8 sites in United States
- Volunteers
- 3,003 people
- Sponsor
- University of Virginia
Nosocomial Infection
New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn
This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.
- Trial name
- NOSODIAG (NCT00701948)
- Where
- 2 sites in France
- Volunteers
- 240 people
- Sponsor
- University Hospital, Strasbourg, France
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
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Amniotic Fluid & the Preterm Gut
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations.
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset
- Trial name
- AMFIBIE (NCT07152106)
- Where
- 2 sites in Netherlands
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Central Line Bloodstream Infections
The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants
The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.
- Trial name
- NCT00964093
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute
Neonatal Late Onset Sepsis
Pentoxifylline Dose Optimization in Neonatal Sepsis
Sepsis is a very important cause of death and morbidity in preterm infants. There are strong indications that preterm neonates with sepsis could benefit, next to antibiotics, from treatment with pentoxifylline (PTX).
- Trial name
- NCT04152980
- Testing
- Pentoxifylline
- Where
- 2 sites in Netherlands, Poland
- Volunteers
- 30 people
- Sponsor
- Erasmus Medical Center
Sepsis
Neonatal Sepsis, Evaluation, Bangladesh
More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis).
- Trial name
- NCT01333982
- Testing
- Amoxycillin, Gentamicin, Counselling
- Where
- Bangladesh
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Sepsis, Prematurity
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected sepsis.
- Trial name
- NCT00850122
- Testing
- cefazolin
- Where
- Brazil
- Volunteers
- 9 people
- Sponsor
- Phillip Brian Smith
Pre-Eclampsia, Intrauterine Growth Restriction
PEPPI Study: Identification of Women at Risk for Placental Dysfunction
The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a…
- Conditions
- Pre-Eclampsia, Intrauterine Growth Restriction, Polycystic Ovary Syndrome, Iron-deficiency
- Trial name
- NCT06115122
- Testing
- Pre-eclampsia screening program
- Where
- Finland
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Oulu University Hospital
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Complication of Prematurity, Immunologic Deficiency Syndromes
Novel Mechanisms and Approaches to Treat Neonatal Sepsis
Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates.
- Trial name
- NCT02554630
- Testing
- Adjuvant, Blood Collection
- Where
- United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- University of Florida