About 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.
Eligibility criteria
Qualifiers
Postmenstrual age > 34 6/7 weeks and Postnatal age ≤ 28 days
On respiratory support (Invasive mechanical ventilation, NIPPV, CPAP, HFNC ≥ 2 LPM) and FiO2 ≥ 0.3
Echocardiographic evidence of pulmonary hypertension
Mean arterial pressure below the threshold for gestational age despite a 10-20 mL/kg fluid bolus
Disqualifiers
Gestational age < 32 weeks
Severe hypoxic respiratory failure (OI > 35 or SpO2 < 75% on 100% FiO2 for > 60 minutes)
Lethal anomalies (e.g., trisomy 13 or 18)
Complex congenital heart disease beyond specified criteria
Trial design
Treatments tested in this trial
- Dopamine administration
- Norepinephrine
Treatment groups
Sponsors and collaborators
University of California, Davis
Lead sponsor
Children's Miracle Network
Collaborator