Clinical trials: Neonatal Late-onset Sepsis
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
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
Late-Onset Neonatal Sepsis
Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).
- Trial name
- EMERAUDE (NCT03299751)
- Testing
- Diagnostic performances of biomarkers combination
- Where
- 2 sites in France
- Volunteers
- 233 people
- Sponsor
- Hospices Civils de Lyon
Vitamin D Deficiency, Osteopenia of Prematurity
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence…
- Conditions
- Vitamin D Deficiency, Osteopenia of Prematurity, Nephrolithiasis, Metabolic Bone Disease
- Trial name
- HIDVID (NCT06199102)
- Testing
- cholecalciferol/ Devikap
- Where
- Poland
- Volunteers
- 130 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Infection, Enterocolitis, Necrotizing
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide…
- Conditions
- Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
- Trial name
- NCT02116699
- Testing
- oropharyngeal mother's milk, oropharyngeal sterile water
- Where
- 5 sites in United States
- Volunteers
- 260 people
- Sponsor
- Endeavor Health
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.
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
Neonatal Catheter Lock for Infection Prevention
For newborns admitted to Neonatal Intensive Care Units (NICUs), one of the main risk factors for late-onset sepsis is the presence of a central venous catheter (CVC), which is often essential for the administration of medications…
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Neonatal Sepsis, Late-Onset
- Trial name
- Neo-CLIP (NCT07585188)
- Testing
- Taurolidine 2% lock, Normal saline lock
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- University of Turin, Italy
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
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn
Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial
The aim was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Feeding; Difficult, Newborn
- Trial name
- NCT03926390
- Testing
- Bovine colostrum
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Infant, Newborn, Diseases, Infant Development
Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32…
- Trial name
- NCT05945017
- Testing
- Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
- Where
- Spain
- Volunteers
- 233 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
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
Neonatal Sepsis, Late-Onset
Population Pharmacokinetics of Amikacin in Neonates
Aminoglycosides such as Amikacin are routinely used in newborns for the treatment of neonatal sepsis due to gram-negative bacilli.
- Trial name
- NCT04867135
- Testing
- Amikacin Sulfate Injection
- Where
- Chile
- Volunteers
- 138 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Necrotizing Enterocolitis, Sepsis
Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants
OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis and duration of hospitalization in low birth weight infants fed with fortified mother's milk supplemented with either fortified…
- Trial name
- NCT00005888
- Testing
- Fortified Pasteurized Donor Human Milk supplement, Preterm Formula supplement
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- National Center for Research Resources (NCRR)
Multi-Drug Resistant Organisms, Late-Onset Sepsis, Neonatal
Using Antibiotics Wisely - An Antimicrobial Stewardship Program
There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among…
- Conditions
- Multi-Drug Resistant Organisms, Late-Onset Sepsis, Neonatal, Antimicrobial Resistance
- Trial name
- NCT04388293
- Testing
- Exposure of interest
- Where
- Canada
- Volunteers
- 2,000 people
- Sponsor
- University of British Columbia
Late-Onset Neonatal Sepsis
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the…
- Trial name
- PIP/TAZO (NCT05981079)
- Testing
- Piperacillin/tazobactam
- Where
- 10 sites in China
- Volunteers
- 332 people
- Sponsor
- Shandong University
Enteral Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum for Preterm Newborns
Feeding intolerance is a common problem in very preterm infants due to their immature digestive system. This intolerance extends the time to full enteral feeding and thereby also prolongs the time on parenteral nutrition (PN).
- Conditions
- Enteral Feeding Intolerance, Necrotizing Enterocolitis, Late-Onset Neonatal Sepsis
- Trial name
- PreColos-RCT (NCT03085277)
- Testing
- Bovine Colostrum, Preterm Formula
- Where
- 8 sites in China
- Volunteers
- 350 people
- Sponsor
- Per Torp Sangild
Late Onset Neonatal Sepsis
Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis
Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin…
- Trial name
- BVPIMNBLOS (NCT02503761)
- Testing
- Meropenem.
- Volunteers
- 100 people
- Sponsor
- Mansoura University
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
Neonatal SEPSIS, Necrotizing Enterocolitis
A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital
This is a cross-sectional study to evaluate the utilities of a panel of biomarkers (Procalcitonin, Interleukin-6, Serum Amyloid A and Apolipoprotein C2) versus the gold standard blood culture result diagnosing late-onset neonatal…
- Trial name
- PISALONS (NCT03578978)
- Testing
- No intervention
- Where
- 2 sites in Malaysia
- Volunteers
- 200 people
- Sponsor
- Clinical Research Centre, Malaysia