NEUROSIS

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

 Coordinatore EBERHARD KARLS UNIVERSITAET TUEBINGEN 

 Organization address address: GESCHWISTER-SCHOLL-PLATZ
city: TUEBINGEN
postcode: 72074

contact info
Titolo: Prof.
Nome: Christian
Cognome: Poets
Email: send email
Telefono: +49 7071 2984742
Fax: +49 7071 293969

 Nazionalità Coordinatore Germany [DE]
 Sito del progetto http://www.neurosis-study.eu/
 Totale costo 7˙380˙329 €
 EC contributo 5˙623˙414 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2007-B
 Funding Scheme CP-FP
 Anno di inizio 2009
 Periodo (anno-mese-giorno) 2009-03-01   -   2015-08-31

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    EBERHARD KARLS UNIVERSITAET TUEBINGEN

 Organization address address: GESCHWISTER-SCHOLL-PLATZ
city: TUEBINGEN
postcode: 72074

contact info
Titolo: Prof.
Nome: Christian
Cognome: Poets
Email: send email
Telefono: +49 7071 2984742
Fax: +49 7071 293969

DE (TUEBINGEN) coordinator 2˙535˙032.50
2    OULUN YLIOPISTO

 Organization address address: Pentti Kaiteran Katu 1
city: OULU
postcode: 90014

contact info
Titolo: Mr.
Nome: Arto
Cognome: Eljander
Email: send email
Telefono: +358 8 5534133
Fax: +358 8 5534170

FI (OULU) participant 681˙470.00
3    CLALIT HEALTH SERVICES

 Organization address address: ARLOZOROV STREET 101
city: TEL AVIV
postcode: 62098

contact info
Titolo: Mr.
Nome: Haim
Cognome: Keren
Email: send email
Telefono: +972 8 9441672
Fax: +972 8 9441401

IL (TEL AVIV) participant 435˙276.80
4    Azienda Ospedaliero Univesitaria Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi

 Organization address address: Via Conca 71
city: Torrette Ancona
postcode: 60020

contact info
Titolo: Prof.
Nome: Virgilio
Cognome: Carnielli
Email: send email
Telefono: +39 60123
Fax: 390716000000

IT (Torrette Ancona) participant 392˙046.80
5    ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

 Organization address address: 3 Avenue Victoria
city: PARIS
postcode: 75004

contact info
Nome: Christophe
Cognome: Misse
Email: send email
Telefono: +33 1 44841770
Fax: +33 1 44841788

FR (PARIS) participant 391˙086.80
6    UNIVERZITA KARLOVA V PRAZE

 Organization address address: Ovocny trh 5
city: PRAHA 1
postcode: 11636

contact info
Nome: Kristyna
Cognome: Matejkova
Email: send email
Telefono: +420 224964264
Fax: +420 22496 4163

CZ (PRAHA 1) participant 350˙886.80
7    ASSOCIATION HOSPITALIERE DE BRUXELLES-CENTRE HOSPITALIER UNIVERSITAIRE SAINT PIERRE

 Organization address address: RUE HAUTE 322
city: BRUXELLES
postcode: 1000

contact info
Titolo: Mrs.
Nome: Patrice
Cognome: Buyck
Email: send email
Telefono: 3225354000
Fax: 3225353024

BE (BRUXELLES) participant 232˙700.00
8    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Dr.
Nome: Annemieke
Cognome: Steenbergen
Email: send email
Telefono: +31 10 7036945
Fax: +31 10 7036801

NL (ROTTERDAM) participant 147˙156.80
9    TECHNISCHE UNIVERSITAET DRESDEN

 Organization address address: HELMHOLTZSTRASSE 10
city: DRESDEN
postcode: 1069

contact info
Titolo: Mr.
Nome: Carsten
Cognome: Glueck
Email: send email
Telefono: +49 351 46342186
Fax: +49 351 46339742

DE (DRESDEN) participant 136˙960.00
10    UNIVERSITAET ZUERICH

 Organization address address: Raemistrasse 71
city: ZURICH
postcode: 8006

contact info
Titolo: Prof.
Nome: Dirk
Cognome: Bassler
Email: send email
Telefono: +41 44 255 53 40
Fax: +41 44 255 44 42

CH (ZURICH) participant 90˙000.00
11    POHJOIS-POHJANMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMA

 Organization address address: KAJAANINTIE 50
city: OULU
postcode: 90220

contact info
Titolo: Prof.
Nome: Mikko
Cognome: Hallman
Email: send email
Telefono: +358 8 3155100
Fax: +358 8 3155559

FI (OULU) participant 86˙560.00
12    ROBERT BOSCH GESELLSCHAFT FUR MEDIZINISCHE FORSCHUNG MBH

 Organization address address: AUERBACHSTRASSE 112
city: STUTTGART
postcode: 70376

contact info
Titolo: Ms.
Nome: Christiane
Cognome: Schmiedl
Email: send email
Telefono: +49 711 81013759
Fax: +49 711 859295

DE (STUTTGART) participant 86˙536.80
13    UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS

 Organization address address: Robert-Koch-Strasse 40
city: GOETTINGEN
postcode: 37075

contact info
Titolo: Ms.
Nome: Christiane
Cognome: Hennecke
Email: send email
Telefono: +49 551 398770
Fax: +49 551 3922593

DE (GOETTINGEN) participant 46˙400.00
14    ARISTOTELIO PANEPISTIMIO THESSALONIKIS

 Organization address address: Administration Building, University Campus
city: THESSALONIKI
postcode: 54124

contact info
Titolo: Ms.
Nome: Georgia
Cognome: Petridou
Email: send email
Telefono: +30 231 0995140
Fax: +30 231 0853283

EL (THESSALONIKI) participant 11˙300.68
15    BELFAST HEALTH AND SOCIAL CARE TRUST

 Organization address address: "Saintfield Road, Knockbracken Healthcare Park"
city: BELFAST
postcode: BT8 8BH

contact info
Titolo: Prof.
Nome: Ian
Cognome: Young
Email: send email
Telefono: +44 28 90632224
Fax: +44 28 90634812

UK (BELFAST) participant 0.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

neurodevelopmental    placebo    practically    effect    oxygen    ga    health    lungs    age    clinical    risk    premature    months    budesonide    survival    corticosteroids    neurosis    centre    benefits    bpd    inflammation    inhalation    secondary    randomised    positive    care    unclear    weeks    bs    corrected    pulmonary    dysplasia    mortality    cs    treatment    bronchopulmonary    preventing    pre    pressure    lung    preterm    adverse    infants    systemic    prohibited    neurodevelopment    morbidity    born   

 Obiettivo del progetto (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.'

Introduzione (Teaser)

Bronchopulmonary dysplasia (BPD) is a chronic lung disorder that is most common among children who are born prematurely. A safe therapy for BPD treatment would be extremely valuable from an individual patient as well as an economic health care perspective.

Descrizione progetto (Article)

BPD involves abnormal development of lung tissue, and is characterised by inflammation and scarring in the lungs. It develops most often in premature babies, who are born with underdeveloped lungs. BPD results in significant morbidity and mortality.

Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids is associated with pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

The EU funded the http://www.neurosis-study.eu (NEUROSIS) project to determine whether early inhalation of corticosteroid budesonide improves survival without BPD at 36 weeks of gestation in infants born between 23 and 27 weeks. NEUROSIS is an international multi-centre randomised controlled blinded study in a population of 850 pre-term infants.

Approvals from the national competent authorities and the research ethics boards have been obtained in all countries. The project will focus on data analysis and the follow-up of neurodevelopmental assessment.NEUROSIS is one of the largest randomised controlled studies in pre-term neonates ever conducted in Europe. Its results have the potential to make an important impact on the economics of premature baby health care.

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