Clinical trials: Neonatal Sepsis, Late-Onset
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
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
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
Sepsis Newborn, Motor Development
Late-onset Sepsis and Development
Neonatal sepsis is classified as early-onset and late-onset sepsis. Early-onset sepsis occurs within the first 72 hours after birth and is associated with a mortality rate of 10-15%.
- Conditions
- Sepsis Newborn, Motor Development, Sensory Integration Dysfunction
- Trial name
- NCT06884969
- Testing
- Test of Sensory Function in Infants, Peabody Motor Development Scale-2
- Where
- Turkey (Türkiye)
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Nigde Omer Halisdemir 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
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.
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
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
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
Human Milk Fortification, Very Low Birth Weight Baby
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm…
- Conditions
- Human Milk Fortification, Very Low Birth Weight Baby, Human Milk Nutrition, Human Milk Feeding
- Trial name
- NCT06870318
- Testing
- No intervention; Observational study
- Where
- 2 sites in Canada, Sweden
- Volunteers
- 355 people
- Sponsor
- The Hospital for Sick Children
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
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
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
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
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
Neonatal Sepsis
Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study…
- Trial name
- NCT02959229
- Testing
- Lactoferrin
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Ain Shams 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
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
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period.
- 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
- ProGreSs (NCT04549220)
- Where
- Uganda
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- St George's, University of London