A Phase 4 interventional study of Dopamine administration and Norepinephrine in Hypotension and Shock, Pulmonary Hypertension of the Newborn (PPHN) and Hypoxemic Respiratory Failure, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of California, Davis · Phase 4, Interventional, and Treatment
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.
Persistent pulmonary hypertension of the newborn (PPHN) is a serious cardiopulmonary disorder characterized by sustained elevation of pulmonary vascular resistance, leading to right-to-left shunting, impaired oxygenation, and increased morbidity and mortality. In addition to hypoxemic respiratory failure, many infants with PPHN develop systemic hypotension. Management of systemic hypotension in this population is complex, as vasoactive medications may have differing effects on systemic and pulmonary circulations.
Dopamine is widely used as first-line therapy for neonatal hypotension because of its dose-dependent dopaminergic and adrenergic effects. However, both animal models and clinical observations suggest that dopamine may increase pulmonary vascular resistance in neonates with PPHN. Norepinephrine, a predominantly alpha-adrenergic agonist with modest beta-adrenergic activity, may provide more selective augmentation of systemic vascular resistance while exerting less influence on pulmonary vascular tone. Despite the increasing clinical use of norepinephrine in neonatal intensive care units, there are no prospective trials comparing dopamine and norepinephrine in neonates with PPHN.
This is a single-center, cluster-randomized, pilot clinical trial enrolling term and late preterm neonates with hypoxemic respiratory failure, echocardiographic evidence of pulmonary hypertension, and systemic hypotension that persists despite initial fluid resuscitation. Eligible infants are assigned by time-based cluster randomization to receive either dopamine or norepinephrine as first-line vasoactive therapy, consistent with standard clinical practice in the neonatal intensive care unit. Informed consent is obtained for research-specific procedures, including serial targeted neonatal echocardiography, while vasoactive medication use follows established clinical protocols.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 30 is below the median of 87 across 590 interventional studies indexed under Hypotension.
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Permissible Comorbidities: CDH, trisomy 21, HIE on hypothermia, PDA, PFO/ASD, VSD \< 2 mm
Exclusion Criteria:
Infants in this group will receive dopamine as their first-line vasopressor. Continuous intravenous dopamine infusion will be initiated at 5 mcg/kg/min and titrated to achieve gestational age appropriate mean arterial blood pressure targets (maximum 20 mcg/kg/min).
Drug: Dopamine administration
Infants in this group will receive norepinephrine as their first-line vasopressor. Continuous intravenous norepinephrine infusion initiated at 0.02 mcg/kg/min and titrated to achieve gestational age appropriate mean arterial blood pressure targets (maximum 1 mcg/kg/min).
Drug: Norepinephrine
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.
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.
SAP/PAP ratio
Ratio of systemic arterial pressure to pulmonary arterial pressure (SAP/PAP)
Time frame: Within 30 hours of vasopressor initiation.
LV Cardiac output
Left Ventricular Cardiac Output calculated with echocardiography
Time frame: Within 30 hours of vasopressor initiation
Oxygenation Indices
FiO₂ (fraction of inspired oxygen), SpO₂ (peripheral oxygen saturation), PaO₂ (arterial oxygen partial pressure), OI (oxygenation index), OSI (oxygen saturation index)
Time frame: Within 30 hours of vasopressor initiation
Use of inhaled nitric oxide (iNO)
Time frame: Within 30 hours of vasopressor initiation
Need for additional vasoactive agents
Time frame: Within 30 hours of vasopressor initiation
Echocardiographic markers of heart function
Right ventricle and Left ventricle function
Time frame: Within 30 hours of vasopressor initiation
Plan to share: Undecided
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Studies of the drug tested here: Norepinephrine
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