Clinical trials: Late-Onset Neonatal Sepsis
Late-Onset Neonatal Sepsis
Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal Sepsis
Background: Neonatal sepsis is the leading cause of mortality in preterm newborns. The autonomic nervous system modulates the response to sepsis through the cholinergic anti-inflammatory reflex.
- Trial name
- NCT05991648
- Testing
- Kangaroo Care (skin-to-skin contact)
- Where
- 3 sites in Colombia
- Volunteers
- 20 people
- Sponsor
- Universidad de la Sabana
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, Early-Onset, Culture Positive Neonatal Sepsis
Molecular Culture for the Diagnosis of Neonatal Sepsis
Rationale: Early diagnosis of sepsis in neonates is complicated as the signs and symptoms are nonspecific. Although blood culture is the gold standard for the diagnosis, false-negative results and long incubation period of 36-72…
- Conditions
- Neonatal Sepsis, Early-Onset, Culture Positive Neonatal Sepsis, Culture Negative Neonatal Sepsis, Clinical Sepsis
- Trial name
- NCT05763680
- Testing
- Molecular Culture
- Where
- Netherlands
- Volunteers
- 2,000 people
- Sponsor
- Jip Groen
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
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
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
Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development.
- Conditions
- Feeding Intolerance, Necrotizing Enterocolitis, Postnatal Growth, Late-Onset Neonatal Sepsis
- Trial name
- FortiColos-Ⅱ (NCT03822104)
- Testing
- Bovine Colostrum, FM85
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Per Torp Sangild
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
Lactoferrin for Prevention of Sepsis in Infants
The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections…
- Trial name
- NEOLACTO (NCT01525316)
- Testing
- Bovine Lactoferrin, Maltodextrin
- Where
- 3 sites in Peru
- Volunteers
- 414 people
- Sponsor
- Universidad Peruana Cayetano Heredia
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
Late Onset Neonatal Sepsis
Neonatal Vancomycin Trial
The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with late onset bacterial sepsis known or suspected…
- Trial name
- NeoVanc (NCT02790996)
- Testing
- Vancomycin
- Where
- 18 sites in Estonia, Greece and 3 more
- Volunteers
- 242 people
- Sponsor
- PENTA Foundation
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
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
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
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island
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
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
Neonatal Late Onset Sepsis
Pentoxifylline and Late Onset Sepsis in Preterm Infants
Hypothesis: The investigators hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus…
- Trial name
- NCT02163174
- Testing
- Pentoxifylline (PTX)
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Abd Elazeez Attala Shabaan
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.