- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967587
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients (IMPROVE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Huddinge, Sweden
- Karolinska University Hospital
-
Uppsala, Sweden
- Uppsala University Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Exclusion criteria:
- Gastroschisis
- Omphalocele
- Peritonitis
- Necrotizing enterocolitis
- Omphalitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neosense Umbilical Catheter
|
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement performance of an intravascular oxygen sensor in the Neosense system.
Time Frame: Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical complications with the Neosense catheter.
Time Frame: During study, up to 8 days
|
The number of occasions when the Neosense catheter had to be removed and the underlying reason.
This includes all anticipated device effects as well as placing the catheter in the wrong vessel, impossible to measure blood pressure, collect blood samples and/or administer fluids.
|
During study, up to 8 days
|
Any deviations from normal procedures when inserting an umbilical catheter.
Time Frame: During day 1
|
Number of attempts to place the catheter for each patient.
Any accessories needed to introduce or handle the Neosense catheter.
|
During day 1
|
Number of monitor lockups or battery depletions
Time Frame: During study, in average 4-5 days
|
Timepoint for monitor lockup or battery depletion, in case of occurrence.
|
During study, in average 4-5 days
|
Usability and functionality of the Neosense monitor.
Time Frame: During study, in average 4-5 days
|
Occurence of anticipated adverse device effects for the monitor.
|
During study, in average 4-5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mats B Blennow, MD, Prof., Karolinska University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IMPROVE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Newborn, Infant, Disease
-
Centre Hospitalier Universitaire de Saint EtienneCompletedInfant, Newborn, DiseaseFrance
-
King's College LondonKing's College Hospital NHS TrustCompletedInfant, Newborn, DiseaseUnited Kingdom
-
Çanakkale Onsekiz Mart UniversityCompletedPosition | Comfort | Newborn, Infant, Disease | ResidualTurkey
-
Lithuanian University of Health SciencesResearch Council of LithuaniaCompletedNewborn, Infant, Disease | Peri-operative InjuryLithuania
-
Turku University HospitalUniversity of TurkuCompletedParent-Child Relations | Parenting | Infant, Newborn, Disease
-
Jerry Vockley, MD, PhDEnrolling by invitationGenetic Disease | Infant, Newborn, DiseaseUnited States
-
Saglik Bilimleri UniversitesiPendik District Health DirectorateCompletedPain | Infant, Newborn, DiseaseTurkey
-
Sharp HealthCareFood and Drug Administration (FDA)CompletedInfant, Newborn, DiseaseUnited States
-
Policlinico Universitario, CataniaRecruitingNewborn Morbidity | Premature Infant DiseaseItaly
-
TC Erciyes UniversityCompletedNewborn, Infant, DiseaseTurkey
Clinical Trials on Neosense Umbilical Catheter
-
Neosense TechnologiesTerminatedLung Diseases | Catheter | Newborn, Infant, DiseaseSweden
-
Xinhua Hospital, Shanghai Jiao Tong University...Shanghai First Maternity and Infant Hospital; Yangpu District Central Hospital...Completed
-
Bundang CHA HospitalWithdrawn
-
Eastern Virginia Medical SchoolCompletedPrematurityUnited States
-
Thomas Jefferson UniversityLata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur...CompletedHypoxic Ischemic Encephalopathy | Umbilical Cord MilkingIndia
-
Acibadem UniversityCompletedCesarean Delivery | Delayed Separation of Umbilical CordTurkey
-
Samsun Education and Research HospitalCompletedPain, Postoperative | Hernia Incisional | Cholelithiasis (Without Cholecystitis)Turkey
-
R3 Stem CellNot yet recruitingStroke | Autoimmune Diseases | Kidney Diseases | Urologic Diseases | Renal Insufficiency | Arthritis | Renal Failure | Alzheimer Disease | Erectile Dysfunction | Cardiomyopathies | Pulmonary Disease | Neurologic Disorder | Orthopedic Disorder | COPD | Cardiac Event | CHF | Neuropathy;Peripheral
-
Fondazione Poliambulanza Istituto OspedalieroCompleted
-
Jubilee Mission Medical College and Research InstituteUnknownHypoxic-Ischemic EncephalopathyIndia