Study Stopped
The clinical investigation IMPROVE-2 has been closed after a decision by the Swedish Medical Products Agency.
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2
IMPROVE-2
1 other identifier
interventional
8
1 country
5
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2023
CompletedSeptember 21, 2023
September 1, 2023
6 months
June 14, 2022
September 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement performance (continuously) 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.
Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)
Secondary Outcomes (6)
Clinical complications with the Neosense catheter.
Time Frame: During study, up to 8 days
Any deviations from normal procedures when inserting an umbilical catheter
During day 1
Number of monitor lock up or battery depletions
During study, in average 4-5 days
Adverse device effects of the Neosense monitor.
During study, in average 4-5 days
Any deviations from normal procedures when inserting an umbilical catheter.
During day 1
- +1 more secondary outcomes
Study Arms (1)
Neosense Umbilical Catheter
EXPERIMENTALInterventions
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter
Eligibility Criteria
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.
- Also:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Danderyd Hospital
Danderyd, Sweden
Karolinska University Hospital
Huddinge, Sweden
Karolinska University Hospital
Solna, Sweden
Södersjukhuset
Stockholm, Sweden
Uppsala University Children's Hospital
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Sindelar, MD PhD
Uppsala University Children's Hospital
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
June 14, 2022
First Posted
June 27, 2022
Study Start
December 15, 2022
Primary Completion
June 16, 2023
Study Completion
June 16, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share