Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorUniversity of California, Davis

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

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Davis

Lead sponsor

Children's Miracle Network

Collaborator