RECRUITINGPhase 4INTERVENTIONAL

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

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Dopamine administration

Infants meeting the inclusion criteria who are randomized to dopamine arm will receive dopamine infusion starting at 5 mcg/kg/min, titrated to mean arterial pressure targets based on gestational age, max dose 20 mcg/kg/min.

DRUG

Norepinephrine

Infants meeting the inclusion criteria who are randomized to norepinephrine arm will receive norepinephrine infusion starting at 0.02 mcg/kg/min, titrated to mean arterial pressure targets based on gestational age, max dose 1 mcg/kg/min.

Locations (1)

UC Davis Children's Hospital

Sacramento, California, United States