Appropriate Dosage of Vasopressor in Neonates and Infants

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

February 15, 2024

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2028

Conditions
HypotensionNeonatal HypotensionIntraoperative Complications
Interventions
DRUG

EPHEDrine Hydrochloride 5 mg/ml

"In the present study, the expected rate of recovery of the internal carotid artery according to the dose of the inotropic agent was similar to that in a previous study in which the fraction maintaining mean arterial pressure within 80% of baseline by dose of inotropic agent was 0.9% for the ephedrine 0.1, 0.6, 0.8, 1. 0, 1.2, and 1.4 doses (mg/kg) were 9.9%, 21%, 41%, 47%, 65.5%, and 40%, respectively (Br J Anaesth. 2023 May;130(5):603-610), and it was assumed that the rate of internal carotid artery recovery by inotrope dose would be 90% of that result.~The study will randomize to dose in six cohorts and will include dose group and cohort variables in a logistic regression model to assess the trend between inotropic dose and rate of carotid revascularization after correcting for cohort effects on the outcome variable."

All Listed Sponsors
lead

Seoul National University Hospital

OTHER

NCT06257316 - Appropriate Dosage of Vasopressor in Neonates and Infants | Biotech Hunter | Biotech Hunter