Clinical trials: Sepsis Newborn
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
Line Insertion Site, Central Line-associated Bloodstream Infection (CLABSI)
Umbilical Cord Care for the Prevention of Colonization
Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care Unit (NICU)and utilized when indicated for up to 7 to 14 days.
- Trial name
- NCT01893060
- Testing
- Povidone-Iodine, Chlorhexidine gluconate, Pluronic Cream
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Virginia
Neonatal SEPSIS, Nosocomially Acquired Neonatal Sepsis
A Study on Ventilator-associated Pneumonia as a Risk for Nosocomial Infection in Mechanically Ventilated Neonates In NICU of Assiut University Children Hospital (Nicu Eta)
Abstract Background: Neonatal ventilator associated pneumonia (VAP) is a major hospital-acquired infection in acute care settings, associated with high mortality and poor outcome.
- Trial name
- nicu eta (NCT03310840)
- Testing
- others
- Where
- Egypt
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Assiut 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
Microbial Colonization, Tolerance
SEPSIS: L. Plantarum Trial
Sepsis is a life-threatening clinical syndrome and a leading cause of neonatal deaths worldwide. The burden of neonatal sepsis and severe infection (SI) is particularly high in areas of South Asia and other resource-limited…
- Conditions
- Microbial Colonization, Tolerance, Safety Issues, Infant ALL
- Trial name
- NCT05180201
- Testing
- Synbiotic, Probiotic
- Where
- 2 sites in Bangladesh
- Volunteers
- 519 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Early-Onset Neonatal Sepsis, Antibiotic Stewardship
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset…
- Trial name
- NCT06197269
- Testing
- Short duration antibiotics, Standard duration antibiotics
- Where
- India
- Volunteers
- 75 people
- Sponsor
- Lady Hardinge Medical College
Sepsis
nSeP: Detecting Neonatal Sepsis by Immune-Metabolic Network Analysis
Diagnosis of neonatal sepsis remains a challenge due to non-specific signs and diagnostic inaccuracies. Studies have shown that this could lead to overdiagnosis and overuse of antibiotic treatment, with potential long-term…
- Trial name
- nSeP (NCT03777670)
- Testing
- Blood test
- Where
- United Kingdom
- Volunteers
- 1,000 people
- Sponsor
- Cardiff and Vale University Health Board
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
Infant, Newborn, Infant, Low Birth Weight
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- IVIG (NCT01203345)
- Testing
- IVIG
- Where
- 8 sites in United States
- Volunteers
- 2,416 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Neonatal Sepsis
Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit
Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance.
- Trial name
- NCT04039152
- Testing
- locally adapted neonatal sepsis treatment protocol
- Where
- Egypt
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Assiut University
Sepsis
Zambia Chlorhexidine Application Trial
This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry…
- Trial name
- ZamCAT (NCT01241318)
- Testing
- Chlorhexidine gluconate (4%), Dry cord care
- Where
- Zambia
- Volunteers
- 77,535 people, healthy volunteers welcome
- Sponsor
- Boston University
Neonatal Sepsis, Preterm Infants
Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis
The goal of this clinical trial is to learn the effect of vitamin D as an adjunctive therapy for preterm neonates with sepsis measured by the outcomes, which are sepsis score and C-reactive protein after 7 days.
- Trial name
- NCT07245277
- Testing
- Vitamin D
- Where
- 2 sites in Indonesia
- Volunteers
- 78 people
- Sponsor
- Universitas Padjadjaran
Trauma, Inflammation
Effect of C1-esterase Inhibitor on Systemic Inflammation in Trauma Patients With a Femur or Pelvic Fracture
Trauma and major operation are associated with an excessive inflammation reaction due to tissue injury. This overwhelming immune response is considered to be a major risk factor in the pathogenesis of late inflammatory…
- Conditions
- Trauma, Inflammation, Sepsis, Multiple Organ Dysfunction Syndrome
- Trial name
- CAESAR (NCT01275976)
- Testing
- C1-esterase inhibitor, Saline 0.9%
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- UMC Utrecht
Neonatal Sepsis
Potential Protective Effect of a Formula Supplemented With Fermented Matrices on the Risk of Developing Neonatal Sepsis
This is a multicenter, randomized, double-blind, placebo controlled trial, with parallel groups and reference group. The aim of the study was to evaluate the hypothesis that an immunonutritional strategy, based on use of…
- Trial name
- NCT04742582
- Testing
- Preterm Infants - fed fermented formula, Preterm Infants - fed standard formula, Pre-term Infants - breastfed
- Where
- Italy
- Volunteers
- 876 people
- Sponsor
- Heinz Italia SpA
Neonatal SEPSIS
NeoAMR Observational Study in Neonatal Sepsis
Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess…
- Trial name
- NCT03721302
- Testing
- Main study clinical sepsis, Microbiology sub study
- Where
- 19 sites in Bangladesh, Brazil and 9 more
- Volunteers
- 3,202 people
- Sponsor
- Drugs for Neglected Diseases
Premature Birth, Respiratory Distress Syndrome in Premature Infant
Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns
Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid.
- Conditions
- Premature Birth, Respiratory Distress Syndrome in Premature Infant, Sepsis, Intraventricular Hemorrhage of Prematurity
- Trial name
- PhyCordPrem (NCT06280872)
- Testing
- Physiological Based Cord Clamping, Differed Cord Clamping
- Where
- 2 sites in Belgium
- Volunteers
- 180 people
- Sponsor
- Queen Fabiola Children's University Hospital
Newborn Sepsis
Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis
Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and…
- Trial name
- IMF-NN (NCT03623503)
- Testing
- Observational study
- Where
- France
- Volunteers
- 58 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Neonatal Sepsis
White Blood Cells and Platelets Indices as a Prognostic Factor in Neonatal Sepsis
Sepsis is a complex condition initiated by a pathogen and mediated by cytokines followed by immune, inflammatory, and coagulation homeostasis disturbances, its evolution being dictated by a complicated balance between pro…
- Trial name
- NCT03880305
- Testing
- complete blood count
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Assiut University
Acute Respiratory Tract Infections, Diarrhea
Home Based Child Care to Reduce Mortality and Malnutrition in Tribal Children of Melghat, India: CRCT
Melghat is poorly developed tribal area in India with very high child mortality \& malnutrition prevalence (grossly inadequate medical facilities). Important health problems.
- Conditions
- Acute Respiratory Tract Infections, Diarrhea, Malaria, Neonatal Sepsis
- Trial name
- HBCC (NCT02473796)
- Testing
- Home based child care
- Where
- India
- Volunteers
- 7,594 people
- Sponsor
- MAHAN Trust