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

STUDY OVERVIEW

This international comparative effectiveness research (CER) study led by Mount Sinai Hospital, Canada, aims to determine the optimal management approach for fluid-unresponsive hypotension in very preterm neonates with suspected late-onset sepsis, comparing the effectiveness and safety of dopamine versus norepinephrine as primary pharmacotherapy, utilizing real-world data from the Canadian Neonatal Network and standardized practices across multiple centers.

STUDY GOALS

The goal of this international study is to compare the effectiveness and safety of dopamine versus norepinephrine as primary pharmacotherapy for fluid-unresponsive hypotension in very preterm neonates with suspected late-onset sepsis, utilizing real-world data and standardized practices across multiple centers.

LOCATION

El Paso, Texas: El Paso Children’s Hospital

INCLUSION CRITERIA

  • Born at ≤32 weeks gestational age and older than 48 hours.

  • Currently receiving Dopamine or Norepinephrine as the main treatment for low blood pressure caused by suspected late-onset sepsis or necrotizing enterocolitis (confirmed by bloodstream infection, whether positive or negative).

exclusion criteria

  • Known chromosomal or genetic abnormalities.

  • Currently receiving primary treatment with medications other than Dopamine or Norepinephrine.

All preterm infants born ≤ 32 weeks gestational age and > 48 hours of life with suspected sepsis with systemic hypotension admitted to the participating sites and meeting the above eligibility criteria will be included in the study.

For more information, visit ClinicalTrials.gov.