RecruitingPhase 4NCT07322133

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

Dopamine vs. Norepinephrine in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure and Systemic Hypotension Due to Pulmonary Hypertension: A Pilot Trial

Sponsor

University of California, Davis

Enrollment

30 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Hypotension and Shock Pulmonary Hypertension of the Newborn (PPHN)Hypoxemic Respiratory Failure

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.

Eligibility

Max Age: 28 Days

Plain Language Summary

Simplified for easier understanding

This study — called DONE — is comparing two medications (dopamine and norepinephrine) used to treat dangerously low blood pressure in newborns who also have pulmonary hypertension (high blood pressure in the lungs). Researchers want to find out which medication works better and is safer for these fragile patients. **You may be eligible if...** - You are a newborn (up to 28 days old) born at more than 34 weeks of pregnancy - You need breathing support and extra oxygen (at least 30% oxygen) - An echocardiogram (heart ultrasound) has confirmed you have pulmonary hypertension - Your blood pressure is below the safe threshold for your gestational age, despite receiving fluids **You may NOT be eligible if...** - You were born before 32 weeks of pregnancy - You have severe oxygen failure that is not responding to treatment - You have a life-limiting condition (like trisomy 13 or 18) - You have a complex heart defect beyond what is listed in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDopamine administration

Infants meeting the inclusion criteria who are randomized to dopamine arm will receive dopamine infusion starting at 5 mcg/kg/min, titrated to mean arterial pressure targets based on gestational age, max dose 20 mcg/kg/min.

DRUGNorepinephrine

Infants meeting the inclusion criteria who are randomized to norepinephrine arm will receive norepinephrine infusion starting at 0.02 mcg/kg/min, titrated to mean arterial pressure targets based on gestational age, max dose 1 mcg/kg/min.