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Surfactant

Curosurf for Congenital Heart Disease

Phase 1
Waitlist Available
Led By Steven Donn, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing whether Curosurf can help infants breathe better and spend less time in the hospital.

Eligible Conditions
  • Congenital Heart Disease
  • Hypoplastic Left Heart Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of days in the Pediatric Cardiothoracic Unit
Number of days of mechanical ventilation
Number of post-operative hospital days
Secondary outcome measures
Changes in dynamic lung compliance post intervention
Changes in oxygen requirements post intervention
Changes in oxygenation index (OI) post intervention
+6 more

Side effects data

From 2016 Phase 3 trial • 88 Patients • NCT01709409
7%
air leak
5%
pulmonary hemorrhage
2%
pulmonary interstitial emphysema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Curosurf (Group 1)
BLES (Group 2)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CurosurfExperimental Treatment1 Intervention
Group II: Sham (air)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Curosurf
2009
Completed Phase 4
~340

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Industry Sponsor
197 Previous Clinical Trials
311,990 Total Patients Enrolled
University of MichiganLead Sponsor
1,782 Previous Clinical Trials
6,364,655 Total Patients Enrolled
Steven Donn, MDPrincipal Investigator - University of Michigan
University of Michigan C.S. Mott Children's Hospital, University of Michigan Hospital, Von Voigtlander Women's Hospital
Tulane University School Of Medicine (Medical School)
Fletcher Allen Hlth Care (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to contribute my data as part of this medical research?

"To be eligible for the trial, subjects must have hypoplastic left heart syndrome and should fall between 1 day old to 12 weeks of age. A total of 60 patients are needed to participate in this research."

Answered by AI

Has Curosurf attained regulatory approval from the FDA?

"The safety profile of Curosurf has been preliminarily assessed at a score of 1, owing to the fact that this is an initial Phase 1 clinical trial and there are restrained amounts of data available in terms of both efficacy and safety."

Answered by AI

What ultimate purpose does this trial seek to accomplish?

"The principal aim of this study, which spans up to one year in duration, is to ascertain the number of days spent by pediatric cardiothoracic patients within their respective units. Secondary objectives include calculating the total amount of individuals requiring ECMO or HFV for pulmonary failure post-surgery as well as evaluating any changes in oxygenation index after therapy until extubation."

Answered by AI

Is this a pioneering attempt to test the efficacy of a certain treatment?

"Presently, Curosurf is the subject of 5 different trials that span 16 cities and 2 countries. In 2020, Chiesi Farmaceutici S.p.A., sponsored an initial study with 60 participants which has since completed its Phase 1 drug evaluation stage; this inaugurated a series of 126 studies in total."

Answered by AI

Does this research endeavor presently accept volunteers?

"Affirmative. In-line with clinicaltrials.gov, the experiment was publicly announced on February 25th 2020 and underwent a revision on April 26th 2022 - suggesting it is still recruiting participants. Sixty people are required from 1 medical facility for this trial to be successful."

Answered by AI

How many participants are engaged in this clinical investigation?

"Affirmative. According to the clinicaltrials.gov, this study was first announced on February 25th 2020 and is now searching for 60 participants amongst a single medical site."

Answered by AI

Does this trial allow for the participation of octogenarians?

"This clinical trial is enrolling patients who are between 1 day and 12 weeks in age."

Answered by AI
~0 spots leftby Mar 2025