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Status:

TERMINATED

Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2

Lead Sponsor:

Neosense Technologies

Conditions:

Catheter

Newborn, Infant, Disease

Eligibility:

All Genders

Phase:

NA

Brief Summary

The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where th...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 16 2023

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT05433779

Start Date

December 15 2022

End Date

June 16 2023

Last Update

September 21 2023

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Danderyd Hospital

Danderyd, Sweden

2

Karolinska University Hospital

Huddinge, Sweden

3

Karolinska University Hospital

Solna, Sweden

4

Södersjukhuset

Stockholm, Sweden