Dopamine versus norepinephrine for low blood pressure in newborns with pulmonary hypertension

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

This pilot test compares norepinephrine and dopamine as the first medicine to raise blood pressure in term and late‑preterm newborns with pulmonary hypertension and hypoxemic respiratory failure.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: N/A to 28 Days
• Sex: All
• Sponsor: University of California, Davis (other)
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT07322133 on ClinicalTrials.gov

What this trial studies

This is a single-center, cluster-randomized pilot trial at UC Davis enrolling term and late‑preterm neonates with echocardiographic pulmonary hypertension, hypoxemic respiratory failure, and systemic hypotension that persists after a fluid bolus. Eligible infants on respiratory support and meeting blood pressure and oxygenation criteria are randomized to receive either dopamine or norepinephrine as first-line vasoactive therapy. The study measures short-term hemodynamic and oxygenation responses after initiation of the assigned vasopressor. The goal is to compare effects on systemic blood pressure and pulmonary vascular tone to inform choice of initial vasopressor in PPHN.

Who should consider this trial

Good fit: Term and late‑preterm infants (postmenstrual age >34 6/7 weeks and postnatal age ≤28 days) on respiratory support with echocardiographic pulmonary hypertension and systemic hypotension despite a 10–20 mL/kg fluid bolus are the intended participants.

Not a fit: Extremely preterm infants (<32 weeks), those with severe refractory hypoxic respiratory failure (OI >35 or SpO2 <75% on 100% FiO2), lethal anomalies, or complex congenital heart disease are excluded and would not be expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, the trial could identify a vasopressor strategy that raises systemic pressure without worsening pulmonary vascular resistance, improving oxygenation and clinical stability for affected newborns.

How similar studies have performed: There are animal and observational data suggesting dopamine may raise pulmonary vascular resistance and norepinephrine may spare the pulmonary circulation, but there are no prior prospective randomized trials directly comparing these drugs in neonates with PPHN.

Eligibility criteria

Inclusion Criteria:

1. Postmenstrual age \> 34 6/7 weeks and Postnatal age ≤ 28 days
2. On respiratory support (Invasive mechanical ventilation, NIPPV, CPAP, HFNC ≥ 2 LPM) and FiO2 ≥ 0.3
3. Echocardiographic evidence of pulmonary hypertension
4. 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

Exclusion Criteria:

1. Gestational age \< 32 weeks
2. Severe hypoxic respiratory failure (OI \> 35 or SpO2 \< 75% on 100% FiO2 for \> 60 minutes)
3. Lethal anomalies (e.g., trisomy 13 or 18)
4. Complex congenital heart disease beyond specified criteria

Where this trial is running

Sacramento, California

• UC Davis Children's Hospital — Sacramento, California, United States (RECRUITING)

Study contacts

• Principal investigator: Deepika Sankaran, MD — UC Davis Health
• Study coordinator: Solomon P Tatagiri, MBBS

Conditions: Hypotension and Shock, Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure, Pulmonary Hypertension, Systemic Hypotension, Vasopressor