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Which blood pressure drug saves more premature babies?

NCT ID NCT05347238

Disease control Sponsor: Mount Sinai Hospital, Canada Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 16, 2026 · Last updated Oct 16, 2026

Summary

Very premature infants with late-onset sepsis often develop dangerously low blood pressure that does not respond to fluids. Doctors commonly use either dopamine or norepinephrine, but they lack clear evidence on which drug works better. This international study compares the two drugs across many hospitals to see which one leads to lower death rates and fewer treatment failures. The findings could help standardize care for these fragile infants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dopamine or norepinephrine, two drugs that raise blood pressure
What this could lead to
If one drug proves better, hospitals could standardize treatment for low blood pressure in premature babies with sepsis, potentially improving survival.
What could go wrong
This is an observational comparison, not a randomized trial, so differences between hospitals could reflect other factors. The results may not apply to all preterm infants or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

21 to 32 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neonatal sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extreme prematurity Late-onset neonatal sepsis Neonatal hypotension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BC Women's Hospital

    RECRUITING

    Vancouver, British Columbia, Canada

  • Banner-University Medical Center Phoenix

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85006, United States

  • CHU Sainte- Justine

    RECRUITING

    Montreal, Quebec, Canada

  • Children's Hospital of Eastern Ontario

    RECRUITING

    Ottawa, Ontario, Canada

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Foothill's Medical Centre

    RECRUITING

    Calgary, Alberta, Canada

  • Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, Canada

  • IWK Health Centre

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, Canada

  • La Paz University Hospital

    RECRUITING

    Madrid, 28046, Spain

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, Canada

  • McMaster Children's Hospital

    RECRUITING

    Hamilton, Ontario, Canada

  • Methodist Healthcare

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Montreal Children's Hospital

    RECRUITING

    Montreal, Quebec, Canada

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Shamir Medical Center

    RECRUITING

    Be’er Ya‘aqov, Israel

  • St.Boniface Hospital

    NOT_YET_RECRUITING

    Winnipeg, Manitoba, Canada

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, Canada

  • University Cork College

    RECRUITING

    Cork, Ireland

  • Victoria General Hospital

    RECRUITING

    Victoria, British Columbia, V8Z 6R5, Canada

  • Windsor Regional Hospital

    RECRUITING

    Windsor, Ontario, Canada

  • Winnipeg Health Sciences Centre

    RECRUITING

    Winnipeg, Manitoba, Canada

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