Dopamine vs. Norepinephrine for Pulmonary Hypertension

(DONE Trial)

Overseen By Solomon P Tatagiri, MBBS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Davis

Disqualifiers: Gestational age < 32 weeks, Severe hypoxic respiratory failure, Lethal anomalies, Complex congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 30 hours

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether dopamine or norepinephrine is more effective in treating newborns with pulmonary hypertension (high blood pressure in the lungs) who also have low blood pressure and breathing problems. Both drugs improve blood vessel function, but they may affect the body differently. The trial will examine each drug's impact on blood flow and oxygen levels in the short term. Newborns receiving breathing support and showing signs of pulmonary hypertension might be suitable candidates for this study. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that both dopamine and norepinephrine are generally safe for humans, but key differences exist. Studies have found that dopamine often treats low blood pressure and slow heart rate. It is considered safe and possibly helpful even for those with high blood pressure in the lungs. However, some research suggests dopamine might increase resistance in lung blood vessels, which could concern certain patients.

Norepinephrine effectively raises blood pressure, particularly in conditions like septic shock. It is often preferred for treating low blood pressure in patients with long-term high blood pressure in the lungs. Norepinephrine may affect the lungs less than dopamine, potentially making it a better option for some individuals.

Both treatments are well-researched and used in various medical situations, but their effects can vary based on personal health needs. Always consult healthcare providers to understand what might be best. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for pulmonary hypertension, which often focus on oral medications or inhaled therapies, dopamine and norepinephrine are both administered intravenously and act quickly as vasopressors. Dopamine increases heart rate and cardiac output, while norepinephrine primarily increases vascular tone to improve blood pressure. Researchers are excited because these treatments offer immediate cardiovascular support, which can be crucial for infants with pulmonary hypertension, providing a potentially faster stabilization than traditional options.

What evidence suggests that this trial's treatments could be effective for pulmonary hypertension?

This trial will compare norepinephrine and dopamine for treating newborns with high blood pressure in the lungs. Research has shown that norepinephrine might be a better choice, as it can improve lung blood flow and raise overall blood pressure without stressing the heart. This is crucial because it helps newborns receive more oxygen without worsening their condition. In contrast, while dopamine can raise blood pressure, it might also increase resistance in the lung's blood vessels, potentially harming newborns with this issue. Participants in this trial will receive either norepinephrine or dopamine to assess their effectiveness in similar cases. ^{1 2 3 4 5}

Who Is on the Research Team?

Deepika Sankaran, MD

Principal Investigator

UC Davis Health

Are You a Good Fit for This Trial?

This trial is for newborns who are more than 34 weeks postmenstrual age and less than 28 days old, with pulmonary hypertension and low blood pressure despite fluid treatment. They must be on respiratory support and have a certain level of oxygen in their blood. Babies with specific heart conditions or other comorbidities like Down syndrome may also join.

Inclusion Criteria

I am on a breathing machine or need high oxygen.

My baby is older than 34 weeks and 6 days in gestational age and less than 28 days old after birth.

I have certain health conditions like CDH, Down syndrome, or specific heart issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive either dopamine or norepinephrine as first-line vasopressor therapy

30 hours

Continuous monitoring in neonatal intensive care unit

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dopamine
• Norepinephrine

Trial Overview

The study compares dopamine to norepinephrine as the first choice of treatment for maintaining blood flow in newborns with high lung pressure and failing respiratory systems. It aims to see which drug better improves heart function and oxygen levels without worsening lung pressure.

How Is the Trial Designed?

Group I: Norepinephrine Arm Active Control 1 Intervention

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).

Group II: Dopamine Arm Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Children's Miracle Network

Collaborator

Trials

23

Recruited

1,800+

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK535451/

Dopamine - StatPearls - NCBI Bookshelf - NIH

Dopamine is a peripheral vasostimulant used in clinical settings to manage low blood pressure, low heart rate, and cardiac arrest.

2.

jpeds.com

jpeds.com/article/S0022-3476(22)00207-4/fulltext

Dopamine and Neonatal Pulmonary Hypertension— ...

Dopamine versus epinephrine for cardiovascular support in low birth weight infants: analysis of systemic effects and neonatal clinical outcomes.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1094553906001271

The effects of dopamine on the respiratory system

DA may have beneficial effects on the respiratory system by decreasing oedema formation and improving respiratory muscle function, but can also have ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07322133

Dopamine vs. Norepinephrine for Hypotension in ...

However, both animal models and clinical observations suggest that dopamine may increase pulmonary vascular resistance in neonates with PPHN.

5.

heart.bmj.com

heart.bmj.com/content/37/5/482

Acute circulatory effects of dopamine in patients with ...

We conclude that dopamine is a safe and potentially useful drug for the treatment of reduced cardiac output, even in patients with pulmonary hypertension.