NCT03967587

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2021

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

May 10, 2019

Last Update Submit

January 17, 2022

Conditions

CathetersOxygen SaturationNewborn, Infant, Disease

Keywords

NeonatalUmbilical ArteriesUmbilical VeinsOxygen Partial Pressure

Outcome Measures

Primary Outcomes (1)

  • Measurement performance of an intravascular oxygen sensor in the Neosense system.

    The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.

    Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)

Secondary Outcomes (4)

  • Clinical complications with the Neosense catheter.

    During study, up to 8 days

  • Any deviations from normal procedures when inserting an umbilical catheter.

    During day 1

  • Number of monitor lockups or battery depletions

    During study, in average 4-5 days

  • Usability and functionality of the Neosense monitor.

    During study, in average 4-5 days

Study Arms (1)

Neosense Umbilical Catheter

EXPERIMENTAL
Device: Neosense Umbilical Catheter

Interventions

Neosense Umbilical CatheterDEVICE

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

Neosense Umbilical Catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Gastroschisis
  • Omphalocele
  • Peritonitis
  • Necrotizing enterocolitis
  • Omphalitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska University Hospital

Huddinge, Sweden

Location

Uppsala University Children's Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mats B Blennow, MD, Prof.

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 30, 2019

Study Start

November 19, 2020

Primary Completion

March 6, 2021

Study Completion

March 6, 2021

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)