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NCT05347238 · ClinicalTrials.gov registry record

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

A clinical trial of Extreme Prematurity and Late-Onset Neonatal Sepsis, sponsored by Mount Sinai Hospital, Canada.

Recruiting
Registry status
550
Enrollment target
20
Study locations

NCT05347238 is a study of Extreme Prematurity and Late-Onset Neonatal Sepsis that is actively recruiting participants, run by Mount Sinai Hospital, Canada. The registered enrollment target is 550 participants, above the 264-participant average among 5 other Extreme Prematurity trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT05347238, a study of Extreme Prematurity and Late-Onset Neonatal Sepsis, is actively recruiting participants, sponsored by Mount Sinai Hospital, Canada.

RECRUITING
Registry status
550 participants
Enrollment target
20
Study locations

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

Extreme Prematurity Late-Onset Neonatal Sepsis Neonatal Hypotension

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

FieldValue
Enrollment Target 550 participants
Start Date 2023-02-06
Est. Completion 2027-03-31

Sponsor

Mount Sinai Hospital, Canada

7 total trials

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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, categorized as an unspecified phase. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 264-participant average among 5 other Extreme Prematurity trials with a reported enrollment target (108% higher). The listed sponsor is Mount Sinai Hospital, Canada, which has 7 total studies on file at ClinicalTrials.gov.

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.

NCT05347238 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Ontario, Quebec, British Columbia.

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.

What interventions are being tested in trial NCT05347238?

The interventions under investigation include: Dopamine (DRUG), Norepinephrine (DRUG).

Who is sponsoring clinical trial NCT05347238?

This trial is sponsored by Mount Sinai Hospital, Canada, which has 7 total clinical trials registered on ClinicalTrials.gov.

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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