Clinical trials: Late-Onset Sepsis, Neonatal
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
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
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
Neonatal SEPSIS
Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis
1. Evaluate the relationship of RDW and severity and mortality in patients with neonatal sepsis . 2. Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of neonatal sepsis .
- Trial name
- NCT03403062
- Volunteers
- 100 people
- Sponsor
- Assiut University
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
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
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
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
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
Late-Onset Neonatal Sepsis
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no…
- Trial name
- NCT04842786
- Testing
- Coconut oil
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
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
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
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)
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
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
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
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
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 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