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Dobutamine for NEOnatal CIRCulatory failure defined by novel biomarkers

Objective

Dobutamine and adrenaline are widely used as second line therapy for systemic hypotension in infants. Dopamine is currently the most widely used first line drug. In neonates, sustained hypotension may, and impaired organ perfusion will, cause brain injury and poor neurodevelopmental outcomes. All three catecholamines are currently used off-label and have different modes of action which may result in potentially harmful haemodynamic effects. No reliable safety or efficacy data exists for the use of these drugs in neonates or newborns. Furthermore, no uniform criteria exist to define hypotension and there is little evidence to support current intervention strategies, which vary widely. Recently, superior vena cava (SVC) flow has been proposed as a more reliable indicator of circulatory failure than low blood pressure and preliminary results suggest Dobutamine is the optimum therapeutic in such cases. NEO-CIRC proposes 1) a randomised placebo controlled trial to provide safety and efficacy data for Dobutamine as a first line inotrope for all gestational ages 2) to perform pre-clinical; pharmacokinetic; pharmacodynamic; metabolomic and pharmacogenomic studies 3) to develop improved biomarkers of hypotension 4) to develop and adapt a formulation of Dobutamine suitable for newborns with the aim to apply for a Paediatric Use Marketing Authorisation. The NEO-CIRC consortium includes international experts in neonatal medicine, pharmacology, pharmacogenomics, drug formulation and pre-clinical neonatal models and an experienced group of experienced multicentre clinical trials NICU’s. Outcomes anticipated include improved biomarkers of organ perfusion; a new consensus definition of neonatal circulatory failure and answers to key clinical practice uncertainties, including variability of response to Dobutamine in common pathophysiologies seen in newborn infants impact on longer term developmental outcomes so important to the patients, families and wider society.

Call for proposal

FP7-HEALTH-2011-single-stage
See other projects for this call

Funding Scheme

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

Coordinator

BRIGHTON AND SUSSEX UNIVERSITY HOSPITALS NHS TRUST
Address
Royal Sussex County Hospital, Eastern Road
BN2 5BE Brighton
United Kingdom
Activity type
Research Organisations
EU contribution
€ 955 780,74
Administrative Contact
Heike Rabe (Prof.)

Participants (17)

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 411 753,60
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
Administrative Contact
Gerard Pons (Prof.)
MEDIZINISCHE HOCHSCHULE HANNOVER
Germany
EU contribution
€ 669 570
Address
Carl-neuberg-strasse 1
30625 Hannover
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Olaf Dammann (Prof.)
Servicio Vasco de Salud Osakidetza
Spain
EU contribution
€ 243 371,02
Address
Alava 45
01006 Vitoria-gasteiz
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Idoia Minguez Alonso (Ms.)
UNIVERSITAET zu LUEBECK
Germany
EU contribution
€ 461 537
Address
Ratzeburger Allee 160
23562 Lubeck
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wolfgang Göpel (Prof.)
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 508 497,96
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Mark Turner (Dr.)
Vestische Caritas-Kliniken GmbH
Germany
EU contribution
€ 68 091
Address
Rottstraße
45711 Dattien
Activity type
Other
Administrative Contact
Claudia Roll (Dr.)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 519 061,60
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Fernando Cabañas (Prof.)
PROVECA LIMITED
United Kingdom
EU contribution
€ 614 357,70
Address
Keckwick Lane Daresbury Innovation Centre Daresbury
WA44FS Halton
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Simon Bryson
KITE INNOVATION (EUROPE) LIMITED
United Kingdom
EU contribution
€ 299 052,80
Address
3M Buckley Innovation Centre
HD1 3BD Huddersfield
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Fleur Geoghegan (Dr.)
MED LIFE SA

Participation ended

Romania
EU contribution
€ 2 730,33
Address
Calea Grivitel 365
010719 Bucuresti
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Adrian Loan Toma (Dr.)
UNIVERSITATEA DE MEDICINA SI FARMACIE IULIU HATIEGANU CLUJ-NAPOCA
Romania
EU contribution
€ 150 142
Address
Victor Babes Street 8
400012 Cluj-napoca
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gabriela Corina Zaharie (Prof.)
SEMMELWEIS EGYETEM
Hungary
EU contribution
€ 119 341,80
Address
Ulloi Utca 26
1085 Budapest
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Miklós Szabó (Prof.)
PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS
Hungary
EU contribution
€ 119 341,80
Address
Vasvari Pal Utca 4
7622 Pecs
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Tibor Ertl (Prof.)
ONORACH LTD
United Kingdom
EU contribution
€ 359 200
Address
Unit 20 Prospect Business Centre Gemini Crescent Dundee Technology Park
DD2 1TY Dundee
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Christene Leiper (Prof.)
DYNAKIN SL
Spain
EU contribution
€ 63 691,20
Address
Vp Parque Tecnologico De Bizkaia
48160 Derio
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Monica Rodriguez (Dr.)
GAZI UNIVERSITESI
Turkey
EU contribution
€ 221 661
Address
Gazi Universitesi Rektorlugu Projeler Koordinasyon Merkezi
06500 Ankara
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ebru Ergenekon (Prof.)
TUFTS MEDICAL CENTER, INC CORPORATION
United States
EU contribution
€ 211 986
Address
Washington Street 800
02111 Boston
Activity type
Research Organisations
Administrative Contact
Ivan Frantz (Dr.)