Search / Trial NCT06616012

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 December 22, 2024

Enrolling by invitation

Keywords

Neonatal Arterial Oxygen Tension Oxygen Therapy

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

Trial Officials

Richard Sindelar, MD, PhD, Associate professor

Principal Investigator

Uppsala University Children's Hospital

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.

Locations

Stockholm, , Sweden

Stockholm, , Sweden

Gothenburg, Halland, Sweden

Lund/Malmö, Skåne, Sweden

Uppsala, Uppland, Sweden

Västerås, Västmanland, Sweden

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0