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.
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
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
Parallel
Dopamine administration
DrugInfants 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.
Norepinephrine
DrugInfants 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.
SAP/PAP ratio
Ratio of systemic arterial pressure to pulmonary arterial pressure (SAP/PAP)
LV Cardiac output
Left Ventricular Cardiac Output calculated with echocardiography
Oxygenation Indices
FiO₂ (fraction of inspired oxygen), SpO₂ (peripheral oxygen saturation), PaO₂ (arterial oxygen partial pressure), OI (oxygenation index), OSI (oxygen saturation index)
Use of inhaled nitric oxide (iNO)
Need for additional vasoactive agents
Echocardiographic markers of heart function
Right ventricle and Left ventricle function
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University of California, Davis
Lead sponsor
Children's Miracle Network
Collaborator
