Dopamine vs. Norepinephrine for hypotension in very preterm infants

• Research type

  Research Study

• Full title

  Dopamine vs. Norepinephrine for hypotension in very preterm infants with late-onset sepsis: An International Comparative Effectiveness Research (CER) Project

• IRAS ID

  357746

• Contact name

  Ajay Sinha

• Contact email

  ajay.sinha@nhs.net

• Sponsor organisation

  Mount Sinai Hospital

• Duration of Study in the UK

  1 years, 8 months, 31 days

• Research summary

  Low blood pressure (BP) requiring treatment with specific medications is a serious complication in very premature neonates (vPN gestational age at birth <=32 weeks) with suspected late-onset sepsis (LOS; defined as infections occurring after 48 hours of birth). In Canada, approximately 250 vPN are treated annually for low BP due to LOS, with a mortality rate of 35-40%. Unlike in adults, there is currently no research to guide treatment in this population. While several medications are used by clinicians, dopamine and norepinephrine are most common. However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice.
  A large-scale patient-level randomized controlled trial would be ideal but is operationally challenging and costly in this population. Comparative Effectiveness Research (CER) is a feasible alternative to generate high-quality information, leveraging real world data (RWD) to compare two or more differences practices already in clinical use.
  This study is an international CER project comparing dopamine and norepinephrine use as first-line treatments for low BP in vPN with LOS. Centers across Canada, the United States, Israel, Ireland, Spain and the United Kingdom have agreed to standardize their practice and participate in this project. We aim to recruit 550 neonates and collect their detailed clinical data and compare outcomes for patients treated in a standardized manner with dopamine to those treated with norepinephrine. The primary outcome is death before discharge. This study will be the first to determine which treatment offers better survival outcomes in this highly vulnerable population and will inform future practice

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  26/EM/0146

• Date of REC Opinion

  3 Jul 2026

• REC opinion

  Favourable Opinion