Clinical trials: Sepses, Neonatal
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
The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis
The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis.
- Trial name
- NCT06191523
- Testing
- Control Group, Treatment Group
- Where
- Indonesia
- Volunteers
- 42 people
- Sponsor
- Universitas Sebelas Maret
Sepsis, PROM, Preterm (Pregnancy)
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth.
- Conditions
- Sepsis, PROM, Preterm (Pregnancy), Early-Onset Neonatal Sepsis, Preterm Premature Rupture of Membrane
- Trial name
- SAUNA (NCT06377397)
- Testing
- Antibiotics
- Where
- 9 sites in India
- Volunteers
- 1,500 people
- Sponsor
- Indian Council of Medical Research
Neonatal Sepsis, Markers
Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis
1. To assess myocardial function in neonates with sepsis using tissue doppler echocardiography. 2. To assess sepsis induced cardiac dysfunction. 3.
- Trial name
- NCT07572916
- Testing
- cardiac troponin, and blood culture
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Assiut University
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
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
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
Neonatal Sepsis
Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis
Assess the efficacy of melatonin as an adjuvant in the treatment of free radical disease in septic preterms receiving melatonin compared to those on conventional treatment through measuring the level of Malondialdehyde as a…
- Trial name
- NCT03295162
- Testing
- Melatonin 10 mg, Conventional treatment of neonatal sepsis
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Mohamed Hussein Metwally
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
Neonatal Sepsis
Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin…
- Trial name
- NCT02954926
- Testing
- IVIG
- Where
- Iran
- Volunteers
- 92 people
- Sponsor
- Hormozgan University of Medical Sciences
Newborn; Infection, Newborn Sepsis
New Protocol for Febrile Neonate Management
The objective of present study was to evaluate clinical and laboratory characteristics of febrile neonate and describe the incidence of SBI in febrile neonates.
- Trial name
- NCT03183531
- Testing
- C reactive protein
- Where
- Turkey (Türkiye)
- Volunteers
- 328 people
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Complication of Prematurity, Immunologic Deficiency Syndromes
Novel Mechanisms and Approaches to Treat Neonatal Sepsis
Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates.
- Trial name
- NCT02554630
- Testing
- Adjuvant, Blood Collection
- Where
- United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- University of Florida
Umbilical Cord Infection, Umbilical Sepsis
Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)
The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates.
- Conditions
- Umbilical Cord Infection, Umbilical Sepsis, Neonatal Sepsis
- Trial name
- NCT05569551
- Testing
- Adhesive pouch
- Where
- Malaysia
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- AIMST University Malaysia
AIDS, Pneumonia
Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies
This study aims to observe the effectiveness of clinical application in guiding anti-infection treatments in AIDS patients with severe pneumonia and/or sepsis using Metagenomic Next-Generation Sequencing-based technology in the…
- Conditions
- AIDS, Pneumonia, Sepsis, Neonatal
- Trial name
- NCT06145841
- Testing
- Pathogen metagenomic next-generation sequencing
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Guangzhou 8th People's Hospital
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
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, 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
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
Sepsis Newborn, Malaria
Immune Dysfunction in Newborn Sepsis
The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.
- Conditions
- Sepsis Newborn, Malaria, Immune Responses
- Trial name
- RECIPAL (NCT03780712)
- Testing
- Non applicable
- Volunteers
- 585 people
- Sponsor
- BioMérieux