Recruiting

Dopamine vs. Norepinephrine

Sponsor:

UCLA

Code:

NCT07322133

Conditions

Hypotension and Shock

Pulmonary Hypertension of the Newborn (PPHN)

Hypoxemic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Dopamine administration

Norepinephrine

Study Details

Brief 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.

Conditions

Hypotension and Shock

Pulmonary Hypertension of the Newborn (PPHN)

Hypoxemic Respiratory Failure

Study ID

NCT07322133

Start date

Oct 30, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

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.

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.

Primary outcome measure

  • SAP/PAP ratio [ Time Frame: Within 30 hours of vasopressor initiation. ]
  • LV Cardiac output [ Time Frame: Within 30 hours of vasopressor initiation ]
  • Oxygenation Indices [ Time Frame: Within 30 hours of vasopressor initiation ]

Central Contacts and Locations

Central contacts

Solomon P Tatagiri, MBBS

916-734-8672solomontp@gmail.com

Locations

UC Davis Children's Hospital

Recruiting

Sacramento, California, United States, 95817

Contacts

Solomon Tatagiri, MBBS

916-734-8672solomontp@gmail.com

Deepika Sankaran, MD

916-734-8672dsankaran@health.ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Pulmonary Hypertension
  • Systemic Hypotension
  • Vasopressor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-08-18.