Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3

NCT06616012 | Enrolling By Invitation

• 1 other identifier: IMPROVE-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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

Catheters, Indwelling; Preterm Birth; Compromised Health

Keywords

neonatal; arterial oxygen tension; oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Clinical complications with the Neosense catheter.

  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 5 days

Secondary Outcomes (1)

• Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system

  Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 5 days)

Study Arms (1)

Neosense Umbilical Catheter

EXPERIMENTAL

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

Device: Neosense umbilical catheter

Interventions

Neosense umbilical catheter DEVICE

The Neosense umbilical catheter is used instead of a standard umbilical catheter

Neosense Umbilical Catheter

Eligibility Criteria

• Age: 0 Years - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Neosense Technologies: lead

Study Sites (6)

Östra/Sahlgrenska University Hospital

Gothenburg, Halland County, Sweden

Location

Skåne University Hospital

Lund/Malmö, Skåne County, Sweden

Location

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Location

Södersjukhuset

Stockholm, Stockholm County, Sweden

Location

Uppsala University Children's Hospital

Uppsala, Uppland, Sweden

Location

Västmanalands Hospital

Västerås, Västmanland County, Sweden

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Richard Sindelar, MD, PhD, Associate professor

  Uppsala University Children's 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: September 24, 2024
• First Posted: September 27, 2024
• Study Start: September 14, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)