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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2021-03-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Catheters Oxygen Saturation Newborn, Infant, Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

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Neosense Umbilical Catheter

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

Intervention Type DEVICE

Eligibility Criteria

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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.
* Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).