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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: f
View:

• 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

⁃ Permissible Comorbidities: CDH, trisomy 21, HIE on hypothermia, PDA, PFO/ASD, VSD \< 2 mm

Locations
United States
California
UC Davis Children's Hospital
RECRUITING
Sacramento
Contact Information
Primary
Solomon P Tatagiri, MBBS
solomontp@gmail.com
916-734-8672
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 30
Treatments
Active_comparator: Dopamine Arm
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).
Active_comparator: Norepinephrine Arm
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).
Sponsors
Collaborators: Children's Miracle Network
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov