## Protocol Section
### Identification Module
**NCT ID:** NCT05433779

**Acronym:** IMPROVE-2

**Brief Title:** Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2

**Official Title:** Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2

#### Organization Study ID Info
**ID:** IMPROVE-2
#### Organization
**Class:** INDUSTRY
**Full Name:** Neosense Technologies
### Status Module
#### Completion Date
**Date:** 2023-06-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-21

**Type:** ACTUAL

**Last Update Submit Date:** 2023-09-15

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2023-06-16

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-15

**Type:** ACTUAL

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2022-06-27
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-14
**Study First Submit QC Date:** 2022-06-22
**Why Stopped:** The clinical investigation IMPROVE-2 has been closed after a decision by the Swedish Medical Products Agency.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Neosense Technologies

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Catheter

- Newborn, Infant, Disease

- Lung Diseases

**Keywords:**

- Neonatal

- Umbilical Arteries

- Oxygen Partial Pressure

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Neosense Umbilical Catheter

**Label:** Neosense Umbilical Catheter

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Neosense Umbilical Catheter

**Description:** The Neosense umbilical catheter is used instead of the routinely used umbilical catheter

**Name:** Neosense Umbilical Catheter

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system

**Time Frame:** Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)

#### Secondary Outcomes

**Description:** 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.

**Measure:** Clinical complications with the Neosense catheter.

**Time Frame:** Time Frame: During study, up to 8 days

**Description:** Number of attempts to place the catheter for each patient.

**Measure:** Any deviations from normal procedures when inserting an umbilical catheter

**Time Frame:** During day 1

**Description:** Timepoint for monitor lock up or battery depletion, in case of occurrence

**Measure:** Number of monitor lock up or battery depletions

**Time Frame:** During study, in average 4-5 days

**Description:** Occurence of anticipated adverse device effects for the monitor.

**Measure:** Adverse device effects of the Neosense monitor.

**Time Frame:** During study, in average 4-5 days

**Description:** Any accessories needed to introduce the Neosense catheter.

**Measure:** Any deviations from normal procedures when inserting an umbilical catheter.

**Time Frame:** During day 1

**Description:** Any accessories needed to handle the Neosense catheter during insertion.

**Measure:** Any deviations from normal procedures when inserting an umbilical catheter.

**Time Frame:** During day 1

### Eligibility Module

**Eligibility Criteria:** 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.

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:

* 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

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Danderyd

**Country:** Sweden

**Facility:** Danderyd Hospital

**Location 2:**

**City:** Huddinge

**Country:** Sweden

**Facility:** Karolinska University Hospital

**Location 3:**

**City:** Solna

**Country:** Sweden

**Facility:** Karolinska University Hospital

**Location 4:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Södersjukhuset

**Location 5:**

**City:** Uppsala

**Country:** Sweden

**Facility:** Uppsala University Children's Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Uppsala University Children's Hospital

**Name:** Richard Sindelar, MD PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Lung Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

### Misc Info Module

- Version Holder: 2024-05-24
