CORDIS
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CORDIS

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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.
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Coordinator

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Address

Geschwister-Scholl-Platz
72074 Tuebingen

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 2 535 032,52

Administrative Contact

Christian Poets (Prof.)

Participants (14)

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BELFAST HEALTH AND SOCIAL CARE TRUST

United Kingdom

UNIVERZITA KARLOVA

Czechia

EU Contribution

€ 350 886,80

OULUN YLIOPISTO

Finland

EU Contribution

€ 681 470

CLALIT HEALTH SERVICES

Israel

EU Contribution

€ 435 276,80

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 391 086,80

Azienda Ospedaliero Univesitaria Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi

Italy

EU Contribution

€ 392 046,80

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 147 156,80

ROBERT BOSCH GESELLSCHAFT FUR MEDIZINISCHE FORSCHUNG MBH

Germany

EU Contribution

€ 86 536,80

POHJOIS-POHJANMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMA

Finland

EU Contribution

€ 86 560

ARISTOTELIO PANEPISTIMIO THESSALONIKIS

Greece

EU Contribution

€ 11 300,68

UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS

Germany

EU Contribution

€ 46 400

TECHNISCHE UNIVERSITAET DRESDEN

Germany

EU Contribution

€ 136 960

ASSOCIATION HOSPITALIERE DE BRUXELLES-CENTRE HOSPITALIER UNIVERSITAIRE SAINT PIERRE

Belgium

EU Contribution

€ 232 700

UNIVERSITAT ZURICH

Switzerland

EU Contribution

€ 90 000

Project information

Grant agreement ID: 223060

Status

Closed project

  • Start date

    1 March 2009

  • End date

    31 August 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 379 459,92

  • EU contribution

    € 5 623 414

Coordinated by:

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany