Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
NCT ID: NCT06616012
Last Updated: 2024-09-27
Study Results
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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ENROLLING_BY_INVITATION
NA
50 participants
INTERVENTIONAL
2023-09-14
2025-03-30
Brief Summary
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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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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Neosense Umbilical Catheter
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter
Neosense umbilical catheter
The Neosense umbilical catheter is used instead of a standard umbilical catheter
Interventions
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Neosense umbilical catheter
The Neosense umbilical catheter is used instead of a standard umbilical catheter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Years
1 Day
ALL
No
Sponsors
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Neosense Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Sindelar, MD, PhD, Associate professor
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Children's Hospital
Locations
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Östra/Sahlgrenska University Hospital
Gothenburg, Halland County, Sweden
Skåne University Hospital
Lund/Malmö, Skåne County, Sweden
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Södersjukhuset
Stockholm, Stockholm County, Sweden
Uppsala University Children's Hospital
Uppsala, Uppland, Sweden
Västmanalands Hospital
Västerås, Västmanland County, Sweden
Countries
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Other Identifiers
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IMPROVE-3
Identifier Type: -
Identifier Source: org_study_id
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