Clinical trials: Neonatal Late Onset Sepsis
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
Sepsis
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB…
- Trial name
- PROABIS (NCT03730636)
- Testing
- PCT dosage
- Where
- France
- Volunteers
- 511 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Late-Onset Neonatal Sepsis, Necrotising Enterocolitis
Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
The PARENT study will examine platelet and endothelial associated proteins in preterm infants being investigated for late onset sepsis (LOS) to see if infants with fulminant sepsis can be prospectively identified using these…
- Conditions
- Late-Onset Neonatal Sepsis, Necrotising Enterocolitis, Culture Negative Neonatal Sepsis
- Trial name
- PARENT (NCT05530330)
- Testing
- Platelet/Endothelial proteomics
- Where
- 2 sites in Ireland
- Volunteers
- 268 people
- Sponsor
- University College Dublin
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
Antibiotic Stewardship, Neonatal Sepsis, Late-Onset
Vancomycin Reduction Practices (VRP) in the NICU
This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs).
- Conditions
- Antibiotic Stewardship, Neonatal Sepsis, Late-Onset, Vancomycin
- Trial name
- NCT06772675
- Testing
- External Facilitation
- Where
- 13 sites in United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
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
Sepsis
Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis
This phase III multicentric international randomized trial is designed to compare the efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical or confirmed late-onset sepsis (LOS).
- Trial name
- NeoMero-1 (NCT01551394)
- Testing
- Meropenem, Ampicillin + gentamicin or cefotaxime + gentamicin
- Where
- Italy
- Volunteers
- 272 people
- Sponsor
- PENTA Foundation
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
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
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
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
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
Preterm, Necrotizing Enterocolitis
The Effect of Probiotics Added to the Mother's Diet on Preterm Babies
Abstract According to the definition by World Health Organization; births before the completion of the 37th gestational week are called, preterm birth.
- Conditions
- Preterm, Necrotizing Enterocolitis, Late-Onset Neonatal Sepsis, Breast Milk Expression
- Trial name
- NCT06118801
- Testing
- Probiotic Product Supplement
- Volunteers
- 50 people
- Sponsor
- Harran University
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
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- PREPARE (NCT04653948)
- Where
- Uganda
- Volunteers
- 3,423 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
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
Neonatal Sepsis
Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis
The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic…
- Trial name
- suPAR (NCT01294865)
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ankara 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
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