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Curosurf for Congenital Heart Disease
Study Summary
This trial is testing whether Curosurf can help infants breathe better and spend less time in the hospital.
- Congenital Heart Disease
- Hypoplastic Left Heart Syndrome
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 88 Patients • NCT01709409Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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