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

RecruitingPhase 4

Sponsor: University of California, Davis

Conditions: Hypotension and Shock, Pulmonary Hypertension of the Newborn (PPHN), Hypoxemic Respiratory Failure

Interventions: Dopamine administration, Norepinephrine

Countries: United States

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 overview

Sex: ALL

Age: — to 28 Days

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Sacramento, California, United States