Clinical trials: Neonatal Infections
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Paediatric Antimicrobial Pharmacokinetics
Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
The aim of NAPPA is to develop new models to improve our understanding of how children process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens used for children in the future.
- Trial name
- NAPPA (NCT01975493)
- Where
- 9 sites in United Kingdom
- Volunteers
- 428 people
- Sponsor
- St George's, University of London
Cytomegalovirus Retinitis, HIV Infections
A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of…
- Trial name
- NCT00002016
- Testing
- Sevirumab
- Where
- 2 sites in United States
- Sponsor
- Sandoz
Neurogenic Detrusor Overactivity
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
- Trial name
- KANGUROO (NCT05491525)
- Testing
- Vibegron
- Where
- 38 sites in United States, Belgium and 14 more
- Volunteers
- 71 people
- Sponsor
- Urovant Sciences GmbH
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Newborn Rds, Transient Tachypnea of the Newborn
LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE
We aimed to decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography. From January 2019 to June 2020, 104 newborn infants with respiratory distress enrolled in this study.
- Conditions
- Newborn Rds, Transient Tachypnea of the Newborn, Pneumonia
- Trial name
- LUDRE (NCT04722016)
- Where
- Turkey (Türkiye)
- Volunteers
- 104 people
- Sponsor
- Hacettepe University
Bacteremia
Increasing the Yield of Blood Cultures in Neonates
The purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for…
- Trial name
- NCT01023555
- Testing
- 1cc of blood in a single aerobic culture bottle
- Volunteers
- 1,500 people
- Sponsor
- Shaare Zedek Medical Center
JOB's Syndrome, Hyper-IgE Recurrent Infection Syndrome
Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome
This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with Hyper-IgE recurrent infection syndrome, a disease characterized by recurrent infections of the ears, sinuses, lungs and skin, and…
- Conditions
- JOB's Syndrome, Hyper-IgE Recurrent Infection Syndrome, Immune Deficiency
- Trial name
- NCT00527878
- Testing
- Ranitidine
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis (CF)
Study With Phage for CF Subjects With Pseudomonas Lung Infection
The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects.
- Trial name
- NCT06998043
- Testing
- BX004
- Where
- 14 sites in United States
- Volunteers
- 63 people
- Sponsor
- BiomX Ltd
Premature Birth, Fetal Growth Retardation
NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health
Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral strategies to the millions of households worldwide that continue to burn solid cooking fuels using inefficient stoves.
- Conditions
- Premature Birth, Fetal Growth Retardation, Infections, Respiratory, Exposure to Environmental Pollution, Non-occupational
- Trial name
- NCT02812914
- Testing
- Low-cost gas stove, Peer education classes, Resource-intensive behavioral intervention approach
- Where
- Guatemala
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Pneumonia Ventilator Associated, Pneumonia Neonatal
Reduction of the Incidence of NAV in Neonatal Units (INBERNAV-Neo)
The aim of this project is to achieve useful, universal and standardized definitions for the diagnosis and prevention of ventilator-associated neumonia in patients in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Pneumonia Ventilator Associated, Pneumonia Neonatal, Healthcare-associated Infections
- Trial name
- INBERNAV-Neo (NCT07240038)
- Testing
- Multimodal intervention to reduce the incidence of ventilator-associated pneumonia by training the health care team in specific and general evidence-based good clinical practices., Technique with a blind-protected catheter
- Where
- 39 sites in Spain
- Volunteers
- 1,500 people
- Sponsor
- Biobizkaia Health Research Institute
Pneumonia
Lung Ultrasound-Guided Positioning Strategy for the Prevention of Ventilator-Associated Pneumonia in Neonates
This study aims to determine if using lung ultrasound to guide personalized positioning for ventilated newborns is more effective than standard repositioning at preventing ventilator-associated pneumonia.
- Trial name
- LUS-POSforVAP (NCT07254507)
- Testing
- standard positioning management, Lung Ultrasound Guided Localization
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Huiyi Li
Gram Negative Infections
A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to < 18 years with…
- Trial name
- NCT06828848
- Testing
- Meropenem plus vaborbactam
- Where
- 22 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Menarini Group
Argininosuccinic Aciduria, Carbamoyl-Phosphate Synthase I Deficiency
The NIH UNI Study: Urea Cycle Disorders, Nutrition and Immunity
Objectives: To study nutrition and immune system problems in people with urea cycle disorders. To study how people with urea cycle disorders and healthy volunteers respond to standard flu and/or hepatitis A vaccines.
- Conditions
- Argininosuccinic Aciduria, Carbamoyl-Phosphate Synthase I Deficiency, Citrullinemia, Ornithine Carbamoyltransferase Deficiency
- Trial name
- NCT01421888
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- National Human Genome Research Institute (NHGRI)
Pre-Term, Neonatal Infection
Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. It is accurate, but needs a long training for new users to assess cardiac function.
- Trial name
- NInHeDyNeo (NCT04200807)
- Testing
- Ultrasound Cardiac Output Monitor (USCOM 1A)
- Where
- Lithuania
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Vilnius University
Skin Infections, Bacterial
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
- Trial name
- NCT00555061
- Testing
- Retapamulin Ointment, 1%
- Where
- 25 sites in United States, Argentina and 7 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
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
Infant, Premature, Diseases, Bronchiolitis
Developing and Evaluating User-Designed Data Displays
Hospitalized children with respiratory disease are commonly monitored with continuous pulse oximetry and heart rate-respiratory rate monitors.
- Trial name
- NCT02615808
- Testing
- Oxygen saturation data visualization
- Where
- United States
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Leukemia, Lymphoma
DT2219ARL for Relapsed or Refractory CD19 (+), CD 22 (+) B-Lineage Leukemia Or Lymphoma
This is a phase I dose escalation study of DT2219ARL for the treatment of relapsed or refractory B-lineage leukemia and lymphoma. Patients will receive a single course of DT2219ARL as a 4 hour infusion on days 1, 3, 5, and 8.
- Trial name
- NCT00889408
- Testing
- DT2219ARL
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
In Utero Drug Exposure
Cardiometabolic Health of Children Exposed to Anti-retroviral Therapy (ART) in Utero
The Human Immunodeficiency Virus (HIV) has been recently linked to increased risk for cardiovascular diseases (CVDs). The prevalence of cardiovascular diseases and its risk factor, hypertension, are very high in African…
- Trial name
- ARTMOMSBABES (NCT04763668)
- Testing
- Pregnant HIV positive women on ARTs, Babies born to HIV positive mothers on ARTs
- Where
- South Africa
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Walter Sisulu University
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