Actively Recruiting
Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
Led by University of California, Davis · Updated on 2026-02-10
30
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
C
Children's Miracle Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenstrual age greater than 34 weeks and 6 days and postnatal age 28 days or less
- Receiving respiratory support including invasive mechanical ventilation, NIPPV, CPAP, or high-flow nasal cannula at 2 liters per minute or more
- Echocardiographic evidence of pulmonary hypertension
- Mean arterial pressure below gestational age threshold despite receiving a 10-20 mL/kg fluid bolus
- Permissible comorbidities include congenital diaphragmatic hernia, trisomy 21, hypoxic ischemic encephalopathy on hypothermia, patent ductus arteriosus, patent foramen ovale or atrial septal defect, and ventricular septal defect smaller than 2 mm
You will not qualify if you...
- Gestational age less than 32 weeks
- Severe hypoxic respiratory failure defined as oxygenation index greater than 35 or oxygen saturation below 75% on 100% oxygen for more than 60 minutes
- Lethal anomalies such as trisomy 13 or 18
- Complex congenital heart disease beyond the specified criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UC Davis Children's Hospital
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
S
Solomon P Tatagiri, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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