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Enrolling by invitation NCT06616012

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

No phase Interventional Catheters, Indwelling Preterm Birth Compromised Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neosense umbilical catheter.
Who it may be relevant to
Registry conditions: Catheters, Indwelling, Preterm Birth, Compromised Health. Basic parameters: 0 years — 1 Day · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • Clinical complications with the Neosense catheter. [Time frame: During study, up to 5 days]
Secondary outcome measures (1)
  • 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 5 days)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Sweden · 6 centers
  • Östra/Sahlgrenska University Hospital — Gothenburg
  • Skåne University Hospital — Lund/Malmö
  • Karolinska University Hospital — Stockholm
  • Södersjukhuset — Stockholm
  • Uppsala University Children's Hospital — Uppsala
  • Västmanalands Hospital — Västerås

Identifiers

NCT: NCT06616012 · IMPROVE-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗