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

NCT ID: NCT05433779

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-06-16

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 the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit.

Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.

The infants will remain in the study as long as the Neosense measuring system is used

Conditions

Catheter; Newborn, Infant, Disease; Lung Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Neosense Umbilical Catheter

Group Type: EXPERIMENTAL

Neosense Umbilical Catheter

Intervention Type: DEVICE

The Neosense umbilical catheter is used instead of the routinely used umbilical catheter

Interventions

Neosense Umbilical Catheter

The Neosense umbilical catheter is used instead of the routinely used umbilical catheter

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neosense Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Sindelar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Children's Hospital

Locations

Danderyd Hospital

Danderyd, , Sweden

Karolinska University Hospital

Huddinge, , Sweden

Karolinska University Hospital

Solna, , Sweden

Södersjukhuset

Stockholm, , Sweden

Uppsala University Children's Hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

IMPROVE-2

Identifier Type: -

Identifier Source: org_study_id