Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
Public support
Provider
Ministry of Education, Youth and Sports
Programme
—
Call for proposals
FP7-HEALTH-2007-B
Main participants
—
Contest type
RP - Co-financing of EC programme
Contract ID
MSMT-1837/2013-310
Alternative language
Project name in Czech
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
Annotation in Czech
HYPOTHESIS: Early inhalation of Budesonide (BS) reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born between 23 and 27 weeks gestational age (GA) by 10%. PRIMARY OBJECTIVE: Survival without BPD at 36 weeks GA. SECONDARY OBJECTIVES: (1) neurodevelopment at a corrected age of 18-22 months; (2) adverse treatment effects; (3) mortality at 36 weeks GA; (4) BPD incidence at 36 weeks GA; (5) duration of positive pressure respiratory support or supplemental oxygen; (6) pharmacokinetic-pharamacodynamic analyses. RATIONALE: Inflammation is central to the development of BPD. Corticosteroids (CS) have antiinflammatory properties and early inhalation of CS may allow for beneficial local effects on the pulmonary system with a lower risk of undesirable systemic side effects. STUDY DESIGN: Randomised placebo-controlled, multi-centre clinical trial and genetic/pharmacogenetic substudy. RESEARCH PLAN: Within 2 years 850 infants of 23-27 weeks GA will be rand
Scientific branches
R&D category
AP - Applied research
CEP classification - main branch
FP - Other medical fields
CEP - secondary branch
—
CEP - another secondary branch
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OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)
30106 - Anatomy and morphology (plant science to be 1.6)<br>30107 - Medicinal chemistry<br>30108 - Toxicology<br>30109 - Pathology<br>30221 - Critical care medicine and Emergency medicine<br>30223 - Anaesthesiology<br>30224 - Radiology, nuclear medicine and medical imaging<br>30225 - Allergy<br>30226 - Rheumatology<br>30227 - Geriatrics and gerontology<br>30229 - Integrative and complementary medicine (alternative practice systems)<br>30230 - Other clinical medicine subjects<br>30307 - Nursing<br>30308 - Nutrition, Dietetics<br>30309 - Tropical medicine<br>30310 - Parasitology<br>30311 - Medical ethics<br>30312 - Substance abuse<br>30501 - Forensic science<br>30502 - Other medical science
Completed project evaluation
Provider evaluation
U - Uspěl podle zadání (s publikovanými či patentovanými výsledky atd.)
Project results evaluation
Following the condition that the candidate of financial contribution was evaluated and afterwards selected by international provider in accordance with the rules of the program the Ministry of Education, Youth ans Sports does not realize the evaluation of project results. The project is evaluated only after its approval by an international provider.
Solution timeline
Realization period - beginning
Apr 1, 2009
Realization period - end
Feb 28, 2014
Project status
U - Finished project
Latest support payment
Feb 27, 2013
Data delivery to CEP
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data delivery code
CEP15-MSM-7E-U/01:1
Data delivery date
Jul 2, 2015
Finance
Total approved costs
3,825 thou. CZK
Public financial support
3,825 thou. CZK
Other public sources
0 thou. CZK
Non public and foreign sources
0 thou. CZK