Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Launched by MOUNT SINAI HOSPITAL, CANADA · Apr 20, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the best medication to treat low blood pressure in very premature infants who may have a serious infection known as late-onset sepsis. The two medications being compared are Dopamine and Norepinephrine, which are often used to help babies whose blood pressure isn't responding to fluids. The goal is to find out which medication is safer and more effective, with hopes that using Norepinephrine might lead to lower death rates among these vulnerable infants.
To be eligible for this study, babies must be born at or before 32 weeks of pregnancy and must be more than 48 hours old. They also need to be receiving one of the two medications due to suspected infections and low blood pressure. Families participating in the trial can expect their baby to receive either Dopamine or Norepinephrine as part of their routine care, depending on what the medical team decides. This trial is important because it aims to improve treatment options for very preterm infants, helping doctors provide the best care possible based on real-world evidence.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • ≤32 weeks gestational age and \> 48 hours of life
- • Receiving primary vasopressor therapy with Dopamine or Norepinephrine in the context of suspected late-onset sepsis or necrotizing enterocolitis with systemic hypotension (defined as: culture positive or negative bloodstream infection)
- Exclusion Criteria:
- • Known chromosomal or genetic anomalies
- • Receiving primary therapy with agents other than Dopamine or Norepinephrine
About Mount Sinai Hospital, Canada
Mount Sinai Hospital, located in Canada, is a leading academic health institution renowned for its commitment to innovative research and high-quality patient care. As a sponsor of clinical trials, Mount Sinai Hospital leverages its extensive expertise in various medical disciplines to advance clinical knowledge and develop new therapies. The hospital collaborates with a diverse network of healthcare professionals, researchers, and institutions to conduct rigorous trials that aim to improve health outcomes and enhance the quality of life for patients. With a focus on ethical standards and patient safety, Mount Sinai Hospital is dedicated to translating scientific discoveries into effective clinical practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Ottawa, Ontario, Canada
Phoenix, Arizona, United States
Dayton, Ohio, United States
Toronto, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Toronto, Ontario, Canada
Halifax, Nova Scotia, Canada
Houston, Texas, United States
Winnipeg, Manitoba, Canada
Dublin, , Ireland
Vancouver, British Columbia, Canada
El Paso, Texas, United States
Hamilton, Ontario, Canada
Montréal, Quebec, Canada
Montréal, Quebec, Canada
Dublin, , Ireland
Be'er Ya'aqov, , Israel
Be'er Ya'aqov, , Israel
San Antonio, Texas, United States
Tel Aviv, , Israel
Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Montréal, Quebec, Canada
Cork, , Ireland
Dublin, , Ireland
San Antonio, Texas, United States
Patients applied
Trial Officials
Amish Jain, MBBS, MRCPCH, PhD
Principal Investigator
Mount Sinai Hospital, Canada
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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