Clinical Trial

Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)

Study acronym: DONE
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2028-01-31 -> 2027-06-30 2026-07-19
minor Completion moved earlier: 2028-01-31 -> 2027-06-30 2026-07-19
Trial Details
NCT Number NCT07322133
Lead Sponsor University of California, Davis
Collaborators: Children's Miracle Network
Conditions Hypotension and Shock, Pulmonary Hypertension of the Newborn (PPHN), Hypoxemic Respiratory Failure
Enrollment 30 participants
Start Date 2026-06-30
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-17