Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
Launched by NEOSENSE TECHNOLOGIES · Sep 24, 2024
Trial Information
Current as of June 30, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Sick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:
- • The infant needs invasive measurement of blood pressure.
- • The infant needs repetitive sampling of blood.
- • The infant needs prolonged infusion(s) \> 2 days.
- • The infant needs infusion of vessel irritating and potentially vessel harming solutions.
- • The infant is born extremely preterm (before 28+0 weeks gestational age).
- • A newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% Fraction of inspired oxygen (FiO2)).
- • The infant is undergoing therapeutic hypothermia following asphyxia \"oxygen deficiency at birth\").
- • The infant has a severe infection/sepsis.
- Also:
- • • Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).
- Exclusion Criteria:
- • Gastroschisis
- • Omphalocele
- • Peritonitis
- • Necrotizing enterocolitis
- • Omphalitis
- • The infant has a severe infection/sepsis
- • Expected MRI investigation within the 7 first days after birth
- • The infants birth weight is below 750 g
- • The infant is born before week 25+0
- • Local vascular compromise in lower limbs or buttocks area, or portal venous hypertension
About Neosense Technologies
Neosense Technologies is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative diagnostic solutions and therapeutic interventions. With a focus on leveraging cutting-edge technology, Neosense aims to enhance patient outcomes by developing and validating novel medical devices and treatments across various therapeutic areas. Committed to rigorous research methodologies, the company collaborates with healthcare professionals and regulatory bodies to ensure the highest standards of safety and efficacy in its clinical trials. Neosense Technologies is positioned at the forefront of transforming patient care through science-driven approaches and a commitment to improving quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, , Sweden
Stockholm, , Sweden
Gothenburg, Halland, Sweden
Lund/Malmö, Skåne, Sweden
Uppsala, Uppland, Sweden
Västerås, Västmanland, Sweden
Lund/Malmö, , Sweden
Västerås, , Sweden
Patients applied
Trial Officials
Richard Sindelar, MD, PhD, Associate professor
Principal Investigator
Uppsala University Children's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported