Actively Recruiting

Phase 4
Age: 0 - 28Days
All Genders
ID07322133

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

Led by University of California, Davis · Updated on 2026-02-10

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

C

Children's Miracle Network

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of dopamine versus norepinephrine as first-line vasoactive treatments in term and late preterm newborns who have pulmonary hypertension related to low oxygen levels and systemic low blood pressure. This trial aims to compare how these drugs affect heart and lung function shortly after treatment begins. Pulmonary hypertension in newborns is a serious condition causing high resistance in lung vessels and poor oxygen delivery, often complicated by low blood pressure requiring medication support. Eligible infants receive either dopamine or norepinephrine through continuous intravenous infusions, adjusted to maintain blood pressure appropriate for their gestational age. Dopamine starts at 5 mcg/kg/min and can be increased to 20 mcg/kg/min, while norepinephrine starts at 0.02 mcg/kg/min and can be increased to 1 mcg/kg/min. This pilot study uses a time-based cluster randomization method, following standard care protocols in the neonatal intensive care unit, with additional echocardiographic monitoring for research purposes. Participants will undergo serial heart ultrasounds and oxygen level assessments within 30 hours after starting the assigned medication. Researchers will measure blood pressure ratios, heart output, oxygenation indices, and the need for other treatments like inhaled nitric oxide. Safety and heart function markers will also be monitored during this period. The study lasts until the primary evaluations are complete, with follow-up aligned to routine clinical care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenstrual age greater than 34 weeks and 6 days and postnatal age 28 days or younger
  • On respiratory support including invasive mechanical ventilation, non-invasive positive pressure ventilation, CPAP, or high-flow nasal cannula at 2 liters per minute or more
  • Echocardiographic evidence of pulmonary hypertension
  • Mean arterial pressure below gestational age thresholds despite receiving a 10-20 mL/kg fluid bolus
  • Permissible comorbidities include congenital diaphragmatic hernia, trisomy 21, hypoxic ischemic encephalopathy on hypothermia, patent ductus arteriosus, patent foramen ovale/atrial septal defect, and ventricular septal defect less than 2 mm
Not Eligible

You will not qualify if you...

  • Gestational age less than 32 weeks
  • Severe hypoxic respiratory failure with oxygenation index over 35 or oxygen saturation below 75% on 100% oxygen for more than 60 minutes
  • Lethal anomalies such as trisomy 13 or 18
  • Complex congenital heart disease beyond specified criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 30 hours after vasopressor initiation

Participants receive either dopamine or norepinephrine as first-line vasoactive therapy to manage systemic hypotension, with dosing adjusted to achieve appropriate blood pressure targets.

Continuous monitoring during infusion and 1 to 2 echocardiography assessments

Trial Site Locations

Total: 1 location

1

UC Davis Children's Hospital

Sacramento, California, United States, 95817

Actively Recruiting

Loading map...

Research Team

S

Solomon P Tatagiri, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Helmet Noninvasive Ventilation vs Continuous Positive Airway...

Respiratory Failure

Actively Recruiting

1 location

The Value of Pleth Variability Index in Predicting Hypotensi...

Hypotension and Shock

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Randomized Trial of Oxygen Saturation Targets during and after Resuscitation and Reversal of Ductal Flow in an Ovine Model of Meconium Aspiration and Pulmonary Hypertension.

Amy L Lesneski, Payam Vali, Morgan E Hardie...

https://pubmed.ncbi.nlm.nih.gov/34356574

Management of systemic hypotension in term infants with persistent pulmonary hypertension of the newborn: an illustrated review.

Heather M Siefkes, Satyan Lakshminrusimha

https://pubmed.ncbi.nlm.nih.gov/33478959

Dopamine effects on pulmonary artery pressure in hypotensive preterm infants with patent ductus arteriosus.

Jean-Michel Liet, Cécile Boscher, Christèle Gras-Leguen...

https://pubmed.ncbi.nlm.nih.gov/11953739