Dopamine vs. Norepinephrine for Pulmonary Hypertension
(DONE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This pilot randomized clinical trial compares dopamine and norepinephrine as first-line vasoactive therapies in term and late preterm neonates with pulmonary hypertension associated with hypoxemic respiratory failure and systemic hypotension. Systemic hypotension is a common and clinically significant complication of persistent pulmonary hypertension of the newborn (PPHN) and frequently requires vasopressor support to maintain adequate systemic perfusion. Dopamine is commonly used in this setting; however, prior animal experimental and clinical data suggest it may increase pulmonary vascular resistance, potentially worsening right ventricular afterload and hypoxemia. Norepinephrine may preferentially increase systemic vascular resistance with less effect on the pulmonary circulation. This study evaluates short-term hemodynamic and oxygenation responses following initiation of dopamine or norepinephrine.
Who Is on the Research Team?
Deepika Sankaran, MD
Principal Investigator
UC Davis Health
Are You a Good Fit for This Trial?
This trial is for newborns who are more than 34 weeks postmenstrual age and less than 28 days old, with pulmonary hypertension and low blood pressure despite fluid treatment. They must be on respiratory support and have a certain level of oxygen in their blood. Babies with specific heart conditions or other comorbidities like Down syndrome may also join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive either dopamine or norepinephrine as first-line vasopressor therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dopamine
- Norepinephrine
Trial Overview
The study compares dopamine to norepinephrine as the first choice of treatment for maintaining blood flow in newborns with high lung pressure and failing respiratory systems. It aims to see which drug better improves heart function and oxygen levels without worsening lung pressure.
How Is the Trial Designed?
2
Treatment groups
Active Control
Infants in this group will receive norepinephrine as their first-line vasopressor. Continuous intravenous norepinephrine infusion initiated at 0.02 mcg/kg/min and titrated to achieve gestational age appropriate mean arterial blood pressure targets (maximum 1 mcg/kg/min).
Infants in this group will receive dopamine as their first-line vasopressor. Continuous intravenous dopamine infusion will be initiated at 5 mcg/kg/min and titrated to achieve gestational age appropriate mean arterial blood pressure targets (maximum 20 mcg/kg/min).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
Children's Miracle Network
Collaborator
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