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

February 5, 2026 updated by: University of California, Davis

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Persistent pulmonary hypertension of the newborn (PPHN) is a serious cardiopulmonary disorder characterized by sustained elevation of pulmonary vascular resistance, leading to right-to-left shunting, impaired oxygenation, and increased morbidity and mortality. In addition to hypoxemic respiratory failure, many infants with PPHN develop systemic hypotension. Management of systemic hypotension in this population is complex, as vasoactive medications may have differing effects on systemic and pulmonary circulations.

Dopamine is widely used as first-line therapy for neonatal hypotension because of its dose-dependent dopaminergic and adrenergic effects. However, both animal models and clinical observations suggest that dopamine may increase pulmonary vascular resistance in neonates with PPHN. Norepinephrine, a predominantly alpha-adrenergic agonist with modest beta-adrenergic activity, may provide more selective augmentation of systemic vascular resistance while exerting less influence on pulmonary vascular tone. Despite the increasing clinical use of norepinephrine in neonatal intensive care units, there are no prospective trials comparing dopamine and norepinephrine in neonates with PPHN.

This is a single-center, cluster-randomized, pilot clinical trial enrolling term and late preterm neonates with hypoxemic respiratory failure, echocardiographic evidence of pulmonary hypertension, and systemic hypotension that persists despite initial fluid resuscitation. Eligible infants are assigned by time-based cluster randomization to receive either dopamine or norepinephrine as first-line vasoactive therapy, consistent with standard clinical practice in the neonatal intensive care unit. Informed consent is obtained for research-specific procedures, including serial targeted neonatal echocardiography, while vasoactive medication use follows established clinical protocols.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAP/PAP ratio
Time Frame: Within 30 hours of vasopressor initiation.
Ratio of systemic arterial pressure to pulmonary arterial pressure (SAP/PAP)
Within 30 hours of vasopressor initiation.
LV Cardiac output
Time Frame: Within 30 hours of vasopressor initiation
Left Ventricular Cardiac Output calculated with echocardiography
Within 30 hours of vasopressor initiation
Oxygenation Indices
Time Frame: Within 30 hours of vasopressor initiation
FiO₂ (fraction of inspired oxygen), SpO₂ (peripheral oxygen saturation), PaO₂ (arterial oxygen partial pressure), OI (oxygenation index), OSI (oxygen saturation index)
Within 30 hours of vasopressor initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of inhaled nitric oxide (iNO)
Time Frame: Within 30 hours of vasopressor initiation
Within 30 hours of vasopressor initiation
Need for additional vasoactive agents
Time Frame: Within 30 hours of vasopressor initiation
Within 30 hours of vasopressor initiation
Echocardiographic markers of heart function
Time Frame: Within 30 hours of vasopressor initiation
Right ventricle and Left ventricle function
Within 30 hours of vasopressor initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Children's Miracle Network

Investigators

  • Principal Investigator: Deepika Sankaran, MD, UC Davis Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2339428
  • GFDS25 (Other Grant/Funding Number: Children's Miracle Network Research Grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoxemic Respiratory Failure

Clinical Trials on Dopamine administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe