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Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

Objective

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 randomised during the first 12 hours of life to BS or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months. CLINICAL SIGNIFICANCE: BPD contributes to the mortality of preterm infants and is associated with impaired neurosensory development and an increased risk of pulmonary morbidity in adolescence and young adulthood. Systemic CS are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of CS has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

Field of science

  • /social sciences/sociology/demography/mortality

Call for proposal

FP7-HEALTH-2007-B
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

EBERHARD KARLS UNIVERSITAET TUEBINGEN
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Geschwister-scholl-platz
72074 Tuebingen
Germany
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Higher or Secondary Education Establishments
EU contribution
€ 2 535 032,52
Administrative Contact
Christian Poets (Prof.)

Participants (14)

BELFAST HEALTH AND SOCIAL CARE TRUST

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United Kingdom
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Lisburn Road Belfast City Hospital A Floor
BT9 7AS Belfast
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Ian Young (Prof.)
UNIVERZITA KARLOVA
Czechia
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€ 350 886,80
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Ovocny Trh 560/5
116 36 Praha 1
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Higher or Secondary Education Establishments
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Kristyna Matejkova
OULUN YLIOPISTO
Finland
EU contribution
€ 681 470
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Pentti Kaiteran Katu 1
90014 Oulu
Activity type
Higher or Secondary Education Establishments
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Arto Eljander (Mr.)
CLALIT HEALTH SERVICES
Israel
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€ 435 276,80
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Arlozorov Street 101
62098 Tel Aviv
Activity type
Research Organisations
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Haim Keren (Mr.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
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€ 391 086,80
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3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Christophe Misse
Azienda Ospedaliero Univesitaria Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi
Italy
EU contribution
€ 392 046,80
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Via Conca 71
60126 Ancona
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Research Organisations
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Virgilio Carnielli (Prof.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
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€ 147 156,80
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Dr Molewaterplein 40
3015 GD Rotterdam
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Annemieke Steenbergen (Dr.)
ROBERT BOSCH GESELLSCHAFT FUR MEDIZINISCHE FORSCHUNG MBH
Germany
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€ 86 536,80
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Auerbachstrasse 112
70376 Stuttgart
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Christiane Schmiedl (Ms.)
POHJOIS-POHJANMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMA
Finland
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€ 86 560
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Kajaanintie 50
90220 Oulu
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Research Organisations
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Mikko Hallman (Prof.)
ARISTOTELIO PANEPISTIMIO THESSALONIKIS

Participation ended

Greece
EU contribution
€ 11 300,68
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Kedea Building, Tritis Septemvriou, Aristotle Univ Campus
54636 Thessaloniki
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Higher or Secondary Education Establishments
Administrative Contact
Georgia Petridou (Ms.)
UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS
Germany
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€ 46 400
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Robert-koch-strasse 40
37075 Goettingen
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Higher or Secondary Education Establishments
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Christiane Hennecke (Ms.)
TECHNISCHE UNIVERSITAET DRESDEN
Germany
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€ 136 960
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Helmholtzstrasse 10
01069 Dresden
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Carsten Glueck (Mr.)
ASSOCIATION HOSPITALIERE DE BRUXELLES-CENTRE HOSPITALIER UNIVERSITAIRE SAINT PIERRE
Belgium
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€ 232 700
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Rue Haute 322
1000 Bruxelles
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Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
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Patrice Buyck (Mrs.)
UNIVERSITAT ZURICH
Switzerland
EU contribution
€ 90 000
Address
Ramistrasse 71
8006 Zürich
Activity type
Other
Administrative Contact
Dirk Bassler (Prof.)