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

Launched by NEOSENSE TECHNOLOGIES · Sep 24, 2024

Keywords

ClinConnect Summary

This study is looking at a new device called the Neosense umbilical catheter and its built-in oxygen monitor in sick newborns who need an umbilical catheter. It is a single-group, non-blinded study that uses the Neosense catheter in place of the usual catheter, and it compares the oxygen readings from the Neosense system with the oxygen readings from standard blood gas tests. The main question is how often the catheter has to be removed and why (for any device problems or placement issues) over up to 5 days. A secondary question is how well the Neosense oxygen readings match the blood gas readings, checked every time a blood sample is taken.

To be eligible, infants must be sick newborns for whom an umbilical catheter is clinically needed and one or more of these apply: invasive blood pressure measurement, frequent blood sampling, long infusions (>2 days), infusions that could harm vessels, extreme prematurity (before 28 weeks), severe lung problems needing high oxygen, cooling after birth injury, or a serious infection. Parents or guardians must give written informed consent. Some infants are not eligible, such as those with certain abdominal wall conditions, early severe infection, very low birth weight (<750 g), birth before 25 weeks, or certain vascular problems. The study is happening in Sweden at several hospitals, currently enrolling by invitation, with an estimated completion around March 2025. The sponsor is Neosense Technologies, and the device used in the trial is not FDA-approved.

Gender

ALL

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) \&gt; 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 \&#34;oxygen deficiency at birth\&#34;).
• • 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