Dopamine vs. Norepinephrine for Low Blood Pressure in Newborns
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Dopamine or Norepinephrine (also known as Levophed or Noradrenaline) is more effective and safer for treating low blood pressure in very preterm infants with suspected late-onset sepsis, a serious infection occurring after 48 hours of age. It compares these two commonly used drugs to determine which one better aids these infants and reduces the risk of death. The study targets babies born at or before 32 weeks who are already receiving these drugs due to severe low blood pressure linked to infections. Participants will receive either Dopamine or Norepinephrine as their primary treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of infants, contributing to important findings that could improve care for preterm babies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be receiving primary treatment with either Dopamine or Norepinephrine to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that dopamine is often used in intensive care units to treat conditions like hypovolemic shock, which occurs when a severe drop in blood pressure results from low blood volume. However, concerns about its safety arise, as studies have reported more safety issues in children using dopamine-related medications for conditions like Tourette syndrome. This indicates that dopamine requires careful monitoring in some cases to prevent side effects.
Conversely, studies on norepinephrine, also used to treat low blood pressure, indicate it is generally safe when monitored properly. Incorrect use, however, can lead to serious problems like high blood pressure spikes, irregular heartbeats, or tissue damage. Despite these risks, norepinephrine has proven effective and safe in both children and adults for raising blood pressure.
Both dopamine and norepinephrine play crucial roles in critical care, and their safety depends on careful dosing and monitoring. While each can have side effects, they remain essential for managing severe low blood pressure.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using dopamine and norepinephrine for treating hypotension in very preterm infants with late-onset sepsis because these treatments may offer new benefits compared to standard care. Unlike conventional treatments that primarily focus on stabilizing blood pressure, dopamine acts by enhancing heart function and improving blood flow to vital organs. Norepinephrine, on the other hand, uniquely targets blood vessels to increase blood pressure by constricting them, potentially offering a more controlled response in critical conditions. Both treatments could provide more precise management of hypotension, which is crucial in the fragile systems of very preterm infants.
What evidence suggests that this trial's treatments could be effective for fluid-unresponsive hypotension in very preterm neonates with suspected late-onset sepsis?
This trial will compare the use of Dopamine and Norepinephrine as first-line agents in different units. Research has shown that norepinephrine can improve outcomes for patients with septic shock. Studies have found that using norepinephrine early can reduce the duration of low blood pressure and decrease mortality rates. For example, one study found that patients receiving norepinephrine had a significantly lower chance of dying in the hospital compared to those who did not receive it. Conversely, dopamine is often used in intensive care for conditions like low blood volume shock. However, there is less specific information on its effectiveness for very premature infants with low blood pressure unresponsive to fluids and suspected late-onset sepsis. Both medications help manage blood pressure, but norepinephrine might be more beneficial in certain critical situations.56789
Who Is on the Research Team?
Amish Jain, MBBS, MRCPCH, PhD
Principal Investigator
Mount Sinai Hospital, Canada
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dopamine or Norepinephrine for fluid-unresponsive hypotension
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are assessed for long-term outcomes such as neurological injury and retinopathy
What Are the Treatments Tested in This Trial?
Interventions
- Dopamine
- Norepinephrine
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Units who have standardized their practice with the use of Norepinephrine as a first line agent.
Units who have standardized their practice with the use of Dopamine as a first line agent.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor
Shamir Medical Center
Collaborator
Hospital Universitario La Paz
Collaborator
BC Women's Hospital & Health Centre
Collaborator
Stony Brook University
Collaborator
The Children's Hospital at Montefiore
Collaborator
Golisano Children's Hospital
Collaborator
Children's Hospital of Eastern Ontario
Collaborator
National Maternity Hospital, Ireland
Collaborator
McMaster Children's Hospital
Collaborator
Citations
Dopamine Function and the Efficiency of Human Movement
The results support the notion that tonic dopamine levels control human sensitivity to the energetic cost of movement.
Dopamine use and its consequences in the intensive care unit
In a national survey conducted in China in 2012, dopamine was found to be the most preferred drug for hypovolemic shock (73.4%) and cardiogenic ...
The effectiveness of off-label dopamine stimulating agents ...
Dopamine agonists such as pramipexole have already been proven effective in reducing depressive symptoms in Parkinson's disease (Bxarone et al., 2010), a ...
Dopamine regulates decision thresholds in human ...
Dopamine fundamentally contributes to reinforcement learning, but recent accounts also suggest a contribution to specific action selection ...
The Role of Dopamine and Its Dysfunction as a Consequence ...
The role of dopamine dysfunction as a consequence of oxidative stress is involved in health and disease.
Safety out of control: dopamine and defence - PMC
We examine aversive processing through the medium of the role of dopamine and targets such as D 2 receptors in the striatum.
Dopaminergic circuits controlling threat and safety learning
This review focuses on dopamine neurons that project to the amygdala, mPFC, and striatum, given their critical role in mediating threat and safety learning.
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neurologylive.com
neurologylive.com/view/real-world-data-highlight-increased-safety-events-dopamine-d2-receptor-antagonists-pediatric-tourette-syndromeReal-World Data Highlight Increased Safety Events of ...
A new study reported that children and adolescents with Tourette syndrome on dopamine D2 receptor antagonists had higher rates of psychiatric ...
A dopaminergic switch for fear to safety transitions
We report that when an expected aversive outcome does not occur, activity in midbrain dopamine neurons is necessary to extinguish behavioral fear responses.
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