Clinical trials: Newborn Sepsis
Neonatal Sepsis, Necrotizing Enterocolitis
Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.
Pakistan has the third highest number of neonatal deaths worldwide. During the last two decades (1990-2013), neonatal mortality rate in the country has declined by only 1.0% per year.
- Trial name
- NCT03431558
- Testing
- bLF (Bovine lactoferrin)
- Where
- Pakistan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Aga Khan 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
Sepsis
Prevention of Infection in Indian Neonates - Phase I Observational Study
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates.
- Trial name
- NCT00518609
- Where
- 3 sites in India
- Volunteers
- 1,326 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Fetal Membranes, Premature Rupture
Perinatal Outcome After Premature Rupture of Membranes
Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection).
- Trial name
- NCT01538030
- Where
- Panama
- Volunteers
- 80 people
- Sponsor
- Saint Thomas Hospital, Panama
Obstetric Labor Complications, Post-partum Hemorrhage
Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE)
The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi Bhagya Yojana) to promote child birth in obstetric facilities in the state of Karnataka, India in order to determine its policy value and to…
- Conditions
- Obstetric Labor Complications, Post-partum Hemorrhage, Sepsis, Pre-eclampsia
- Trial name
- IMATCHINE (NCT01480544)
- Testing
- Experimental: Treatment 1, Experimental: Treatment 2
- Where
- India
- Volunteers
- 14,990 people
- Sponsor
- Duke University
Sepsis
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB…
- Trial name
- PROABIS (NCT03730636)
- Testing
- PCT dosage
- Where
- France
- Volunteers
- 511 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Hepatitis B Infection, Congenital Malformation
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection.
- Conditions
- Hepatitis B Infection, Congenital Malformation, Birth Defect, Viremia
- Trial name
- NCT03476083
- Testing
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Where
- 7 sites in China
- Volunteers
- 280 people
- Sponsor
- New Discovery LLC
Neonatal Sepsis, Omphalitis
A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns
Introduction: Neonatal sepsis in one of the leading cause of death in developing countries. Umbilical cord care is important as it may lead to infection.
- Trial name
- NCT06002295
- Testing
- Chlorhexidine Topical Cream, Methylated Spirit
- Where
- Pakistan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
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
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
Chorioamnionitis, Puerperal Endometritis
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal…
- Conditions
- Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis
- Trial name
- NCT01633294
- Testing
- Ampicillin + gentamicin
- Where
- Portugal
- Volunteers
- 161 people
- Sponsor
- Hospital de Santa Maria, Portugal
Necrotizing Enterocolitis, Intraventricular Hemorrhage
PUFAs in Preterm Infants
The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic…
- Conditions
- Necrotizing Enterocolitis, Intraventricular Hemorrhage, BPD - Bronchopulmonary Dysplasia, Sepsis
- Trial name
- PIPI (NCT06045130)
- Volunteers
- 600 people
- Sponsor
- The First Hospital of Jilin University
Premature Birth, Fragility
Wireless MicroPremVitals Button Sensor in the NICU
A wireless and miniaturized vital sign (ECG, SpO2, Skin Temperature) sensor system, MicroPremVitals Button Sensors was developed by the Dr.
- Conditions
- Premature Birth, Fragility, Apnea of Prematurity, Bradycardia Neonatal
- Trial name
- NCT07732257
- Testing
- Wireless MicroPremVitals Button Sensor System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Septic Shock
Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock
object name: Lung ultrasound-guided fluid resuscitation in neonatal septic shock. type of study: prospective observational study.
- Trial name
- LUGFRINSS (NCT06144463)
- Testing
- lung ultrasound-guided fluid resuscitation
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Guangdong Second Provincial General Hospital
Neonatal SEPSIS, Necrotizing Enterocolitis
A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital
This is a cross-sectional study to evaluate the utilities of a panel of biomarkers (Procalcitonin, Interleukin-6, Serum Amyloid A and Apolipoprotein C2) versus the gold standard blood culture result diagnosing late-onset neonatal…
- Trial name
- PISALONS (NCT03578978)
- Testing
- No intervention
- Where
- 2 sites in Malaysia
- Volunteers
- 200 people
- Sponsor
- Clinical Research Centre, Malaysia
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 Hypocalcemia, Neonatal Sepsis
Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system.
- Trial name
- NCT02147327
- Volunteers
- 120 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Cardiogenic Shock, Malignant Arrhythmias
The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana.
- Conditions
- Cardiogenic Shock, Malignant Arrhythmias, Ischemic or Valvular Heart Failure, Drepanocytosis and Thoracic Syndrome
- Trial name
- NCT07351435
- Volunteers
- 1,200 people
- Sponsor
- University of Genova
Neonatal SEPSIS
The Role of Neutrophil CD64 and Soluble Triggering Receptor Expressed on Myeloid Cells 1 in Neonatal Sepsis
Neonatal sepsis (NS) is a rather serious but relatively common health problem. Despite recent advances in the treatment of neonatal infection, mortality and comorbidities remain high.
- Trial name
- NCT03795285
- Testing
- Expression of neutrophil CD64
- Volunteers
- 50 people
- Sponsor
- Assiut University