Status:

RECRUITING

Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis

Lead Sponsor:

Mount Sinai Hospital, Canada

Collaborating Sponsors:

Sunnybrook Health Sciences Centre

The Hospital for Sick Children

Conditions:

Late-Onset Neonatal Sepsis

Extreme Prematurity

Eligibility:

All Genders

21-32 years

Brief Summary

Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative blo...

Detailed Description

In this study, we will use real world data (RWD; defined as data generated during routine clinical practice) collected by our national Canadian Neonatal Network (CNN), which will be further expanded f...

Eligibility Criteria

Inclusion

  • ≤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

  • Known chromosomal or genetic anomalies
  • Receiving primary therapy with agents other than Dopamine or Norepinephrine

Key Trial Info

Start Date :

February 6 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 31 2027

Estimated Enrollment :

550 Patients enrolled

Trial Details

Trial ID

NCT05347238

Start Date

February 6 2023

End Date

March 31 2027

Last Update

July 8 2025

Active Locations (23)

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Page 1 of 6 (23 locations)

1

Banner-University Medical Center Phoenix

Phoenix, Arizona, United States, 85006

2

Dayton Children's Hospital

Dayton, Ohio, United States, 45404

3

Methodist Healthcare

San Antonio, Texas, United States, 78229

4

Foothill's Medical Centre

Calgary, Alberta, Canada