ClinConnect ClinConnect Logo
Search / Trial NCT05347238

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.

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

0 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

Similar Trials