Clinical trials: Neonatal Late Onset Sepsis
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
Late Onset Neonatal Sepsis, Necrotising Enterocolitis
Lactoferrin Prophylaxis in VLBW and Regulator T-cells
The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.
- Conditions
- Late Onset Neonatal Sepsis, Necrotising Enterocolitis, Very Low Birth Weight Infants
- Trial name
- NCT01287507
- Testing
- Lactoferrin (bovine origin)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Ankara University
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
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
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
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
Necrotising Enterocolitis, Late-Onset Neonatal Sepsis
Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS).
- Trial name
- NEC (NCT04792918)
- Where
- 2 sites in Switzerland
- Volunteers
- 81 people
- Sponsor
- Emma Marie Caroline Slack
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serocorrelate of Protection Against GBS (PREPARE WP3)
A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and…
- 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
- NCT04732026
- Where
- 6 sites in France, Italy and 4 more
- Volunteers
- 600 people
- Sponsor
- St George's, University of London
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)
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
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
Inflammation Indices, Late Onset Neonatal Sepsis
Late-Onset Neonatal Sepsis: A Case-Control Study
The diagnosis of late-onset sepsis in term neonates has been studied less than that of early-onset sepsis. Procalcitonin (PCT) and C-reactive protein (CRP) are commonly used biomarkers in the diagnosis of sepsis.
- Trial name
- Sepsis (NCT07635264)
- Testing
- serum biomarker
- Where
- Turkey (Türkiye)
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Mersin University
Late-onset Sepsis
Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis
The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days
- Trial name
- NCT02424734
- Testing
- Ceftaroline Fosamil, Ampicillin, Aminoglycoside
- Where
- 4 sites in United States, Hungary
- Volunteers
- 11 people
- Sponsor
- Pfizer
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
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