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

Study acronym: DONE
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Start date: Jun 30, 2026 to Oct 30, 2026v5
  2. Minor Primary and study completion moved earlier from Jan 31, 2028 to Jun 30, 2027
    • Start date: Jun 1, 2026 to Jun 30, 2026
    v4
  3. Notable Start date: Jan 1, 2026 to Jun 1, 2026v3
  4. Minor Study title shortened, about 3 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07322133
Lead Sponsor University of California, Davis
Collaborators: Children's Miracle Network
Conditions
(from sponsor)
Hypotension and Shock, Pulmonary Hypertension of the Newborn (PPHN), Hypoxemic Respiratory Failure
Related terms Hypertension, Pulmonary, Hypotension, Respiratory Insufficiency, Shock
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov