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Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
NCT05347238 · View on ClinicalTrials.gov ↗
Study 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 bloodstream infection or necrotizing enterocolitis occurring \>48 hours of age). In Canada, \~250 very preterm neonates receive cardiotropic drugs for LOS related fluid-unresponsive hypotension every year; of these \~35-40% die. Unlike for adult patients, there is little evidence to inform practice. While several medications are used by clinicians, the most frequently used medications are Dopamine (DA) and Norepinephrine (NE). However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice. Conducting large randomized trials in this subpopulation can be operationally challenging and expensive. Comparative effectiveness research (CER), is a feasible alternative which can generate high-quality real-world evidence using real-world data, by comparing the impact of different clinical practices. 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 th
Conditions Studied
Interventions
- DRUG Dopamine
- DRUG Norepinephrine
Study Locations (20)
Ontario
- McMaster Children's Hospital — Hamilton
- London Health Sciences Centre — London
- Children's Hospital of Eastern Ontario — Ottawa
- Hospital for Sick Children — Toronto
- Mount Sinai Hospital — Toronto
- Sunnybrook Health Sciences Centre — Toronto
- Windsor Regional Hospital — Windsor
Quebec
- CHU Sainte- Justine — Montreal
- Jewish General Hospital — Montreal
- Montreal Children's Hospital — Montreal
British Columbia
- BC Women's Hospital — Vancouver
- Victoria General Hospital — Victoria
Manitoba
- St.Boniface Hospital — Winnipeg
- Winnipeg Health Sciences Centre — Winnipeg
Arizona
- Banner-University Medical Center Phoenix — Phoenix
Ohio
- Dayton Children's Hospital — Dayton
Texas
- Methodist Healthcare — San Antonio
Alberta
- Foothill's Medical Centre — Calgary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2023-02-06 |
| Est. Completion | 2027-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05347238
The ClinicalTrials.gov registry entry for NCT05347238 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mount Sinai Hospital, Canada, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Extreme Prematurity appearing as the primary indexed condition, and to 2 interventions — of which Dopamine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05347238 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Ontario, Quebec, British Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05347238 about?
NCT05347238 is a clinical study titled "Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis". 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 bloodstream infection or necrotizing enterocolitis occurring \>48 hours of age). In Canada, \~250 very ...
What is the current status of trial NCT05347238?
This trial is currently recruiting. The enrollment target is 550 participants. The study started on 2023-02-06. Estimated completion is 2027-03-31.
What conditions does trial NCT05347238 study?
This clinical trial studies the following conditions: Extreme Prematurity, Late-Onset Neonatal Sepsis, Neonatal Hypotension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05347238?
The interventions under investigation include: Dopamine (DRUG), Norepinephrine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05347238?
This trial is sponsored by Mount Sinai Hospital, Canada, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05347238 being conducted?
This trial has 20 study locations across Arizona, Ohio, Texas, Alberta, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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