Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
NCT ID: NCT05347238
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
550 participants
OBSERVATIONAL
2023-02-06
2027-03-31
Brief Summary
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Aim: To conduct an international CER study, using a pragmatic clinical trial design, in conjunction with the existing infrastructure of the Canadian Neonatal Network to identify the optimal management of hypotension in very preterm neonates with suspected LOS.
Objective: To compare the relative effectiveness and safety of pharmacologically equivalent dosages of DA versus NE for primary pharmacotherapy for fluid-unresponsive hypotension in preterm infants born ≤ 32 weeks gestational age with suspected LOS.
Hypothesis: Primary treatment with NE will be associated with a lower mortality
Methods: This CER project will compare management approach at the unit-level allowing inclusion of all eligible patients admitted during the study period. 16 centers in Canada, 2 centers in Ireland, 1 center in each of Israel, Spain and the UK, and 6 centers in the United States have agreed to standardize their practice. All eligible patients deemed circulatory insufficient will receive fluid therapy (minimum 10-20 cc/kg). If hypotension remains unresolved:
Dopamine Units: start at 5mics/kg/min, increase every 16-30 minutes by 5 mics/kg/min to a maximum dose of 15 mics/kg/min or adequate response
Norepinephrine Units: start at 0.05 mics/kg/min, increase every 16-30 minutes by 0.05 mics/kg/min to maximum dose of 0.15/mics/kg/min or adequate response
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Detailed Description
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The CNN is a well-established patient registry that includes members from 31 hospitals and 17 universities across Canada. The Network maintains a standardized NICU database and provides a unique opportunity for researchers to participate in collaborative projects. We will use the framework of Hypotheses Evaluating Treatment Effectiveness (HETE) research a form of comparative effectiveness research (CER).
Patient registries are emerging as a new method for assessment of treatments under the framework of CER. We will evaluate treatment effectiveness of two routinely used primary therapies for hypotension management in very preterm neonates with suspected LOS after standardizing treatment strategies and with a priori hypothesis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dopamine Units
Units who have standardized their practice with the use of Dopamine as a first line agent.
Dopamine
Start at 5mics/kg/min, increase every 16-30 minutes by 5 mics/kg/min to a maximum dose of 15 mics/kg/min or adequate response.
Norepinephrine Units
Units who have standardized their practice with the use of Norepinephrine as a first line agent.
Norepinephrine
Start at 0.05 mics/kg/min, increase every 16-30 minutes by 0.05 mics/kg/min to maximum dose of 0.15/mics/kg/min or adequate response
Interventions
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Dopamine
Start at 5mics/kg/min, increase every 16-30 minutes by 5 mics/kg/min to a maximum dose of 15 mics/kg/min or adequate response.
Norepinephrine
Start at 0.05 mics/kg/min, increase every 16-30 minutes by 0.05 mics/kg/min to maximum dose of 0.15/mics/kg/min or adequate response
Eligibility Criteria
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Inclusion Criteria
* 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
* Receiving primary therapy with agents other than Dopamine or Norepinephrine
21 Weeks
32 Weeks
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
The Hospital for Sick Children
OTHER
London Health Sciences Centre
OTHER
Windsor Regional Hospital
OTHER
Foothills Medical Centre
OTHER
Health Sciences Centre, Winnipeg, Manitoba
OTHER
St. Boniface Hospital
OTHER
Jewish General Hospital
OTHER
St. Justine's Hospital
OTHER
IWK Health Centre
OTHER
University College Cork
OTHER
Coombe Women and Infants University Hospital
OTHER
Island Health, Victoria, BC
OTHER
Assaf-Harofeh Medical Center
OTHER_GOV
Dayton Children's Hospital
OTHER
Banner University Medical Center
OTHER
Methodist Healthcare
OTHER
Hospital Universitario La Paz
OTHER
McMaster Children's Hospital
OTHER
Children's Hospital of Eastern Ontario
OTHER
BC Women's Hospital & Health Centre
OTHER
Stony Brook University
OTHER
The Children's Hospital at Montefiore
OTHER
Golisano Children's Hospital
UNKNOWN
Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Principal Investigators
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Amish Jain, MBBS, MRCPCH, PhD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital, Canada
Locations
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Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Methodist Healthcare
San Antonio, Texas, United States
Foothill's Medical Centre
Calgary, Alberta, Canada
BC Women's Hospital
Vancouver, British Columbia, Canada
Victoria General Hospital
Victoria, British Columbia, Canada
St.Boniface Hospital
Winnipeg, Manitoba, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
CHU Sainte- Justine
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
University Cork College
Cork, , Ireland
Coombe Women & Infants University Hospital
Dublin, , Ireland
Shamir Medical Center
Be’er Ya‘aqov, , Israel
La Paz University Hospital
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Suma Rao
Role: primary
Shreyas Arya
Role: primary
Melissa Althouse, MD
Role: primary
Amuchou Soraisham
Role: primary
Michael Castaldo
Role: primary
Yasser ElSayed
Role: primary
Deepak Louis
Role: primary
Walid El Naggar
Role: primary
Amneet Sidhu
Role: primary
Soume Bhattacharya
Role: primary
Laurent Renesme
Role: primary
Bonny Jasani
Role: primary
Sajit Augustine
Role: primary
Anie Lapointe
Role: primary
Nina Nouraeyan
Role: primary
Gabriel Altit
Role: primary
Eugene Dempsey
Role: primary
Jan Miletin
Role: primary
Sagee Nissimov
Role: primary
Other Identifiers
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CTO 4009
Identifier Type: -
Identifier Source: org_study_id
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