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Management of Hypotension In the Preterm Extremely Low Gestational Age Newborn

Objective

Assuming an annual birth rate of 10.25 births/1,000 population approximately 25,000 Extremely Low Gestational Age Newborns are born every year in the EU. Conservative figures estimate that approximately half of all these babies will develop low blood pressure and require treatment. However, no uniform criteria exist to define hypotension and the evidence to support our current management strategies is limited. Many of these interventions have been derived from adult literature and have not been validated in the newborn. Dopamine remains the most common inotrope used despite little evidence that it improves outcome. Hypotension is not only associated with mortality of preterm infants but is also associated with brain injury and impaired neurosensory development in ELGAN survivors. Preterm brain injury has far reaching implications for the child, parents, family, health service and society at large. It is therefore essential that we now design and perform the appropriate trials to determine whether the infusion of inotropic agents is associated with improved outcome. We have assembled a consortium with expertise in key areas of neonatal cardiology, neonatology, neurophysiology, basic science and pharmacology with the intention of answering these questions. The objectives of the group are as follows:
1. To perform a multinational, randomized controlled trial to evaluate whether a more restricted approach to the diagnosis and management of hypotension compared to a standard approach, with dopamine as a first line inotrope, affects survival without significant brain injury at 36 weeks gestational age in infants born less than 28 weeks gestation and affects survival without neurodevelopmental disability at 2 years corrected age
2. To perform pharmacokinetic and pharmcodynamic studies of dopamine
3. To develop and adapt a formulation of dopamine suitable for newborns in order to apply for a Paediatric Use Marketing Authorization

Field of science

  • /humanities/languages and literature/literature - general
  • /social sciences/sociology/demography/fertility
  • /social sciences/sociology/demography/mortality
  • /medical and health sciences/clinical medicine/cardiology
  • /medical and health sciences/basic medicine/pharmacology and pharmacy

Call for proposal

FP7-HEALTH-2010-single-stage
See other projects for this call

Funding Scheme

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

Coordinator

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK
Address
Western Road
T12 YN60 Cork
Ireland
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 296 306
Administrative Contact
David O'connell (Dr.)

Participants (16)

KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 483 936,30
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Elke Lammertyn (Dr.)
UNIVERZITA KARLOVA
Czechia
EU contribution
€ 208 872
Address
Ovocny Trh 560/5
116 36 Praha 1
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jaromír Chlapec (Mr.)
CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
Canada
EU contribution
€ 243 375,75
Address
Cote Sainte Catherine 3175 Etage C Bloc 5
H3T 1C5 Montreal Quebec
Activity type
Research Organisations
Administrative Contact
Jean Langlais (Dr.)
UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland
EU contribution
€ 179 087
Address
Belfield
4 Dublin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Donal Doolan (Mr.)
THE COOMBE LYING-IN HOSPITAL
Ireland
EU contribution
€ 438 738,30
Address
Dolphins Barn Cork Street
Dublin 8 Dublin
Activity type
Research Organisations
Administrative Contact
Patrick Donohue (Mr.)
CLININFO SA
France
EU contribution
€ 67 575
Address
Rue De Gerland 99 Entree 7
69007 Lyon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Patrick Chevarier (Mr.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
EU contribution
€ 100 000
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Greta Borg-Carbott (Ms.)
BREPCO BIOPHARMA LTD
Ireland
EU contribution
€ 888 000
Address
Suite One, The Avenue, Beacon Court, Sandyford
D18 Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Seamus Oloan (Mr.)
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 305 004,43
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs (Ms.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 511 500
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
Administrative Contact
Nicolas Jeanjean (Mr.)
THE GOVERNORS OF THE UNIVERSITY OF ALBERTA UNIVERSITY OF ALBERTA
Canada
EU contribution
€ 183 586,50
Address
Street 8625 112 Campus Tower 222 Research Services Office
T6G 2E1 Edmonton Alberta
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Lorraine Deydey (Ms.)
ROYAL COLLEGE OF SURGEONS IN IRELAND
Ireland
EU contribution
€ 162 635,40
Address
Saint Stephen's Green 123
2 Dublin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Barry Mcgowan (Mr.)
UNIVERSITAIR ZIEKENHUIS ANTWERPEN
Belgium
EU contribution
€ 60 000
Address
Wilrijkstraat 10
2650 Edegem
Activity type
Research Organisations
Administrative Contact
Daisy Van Mieghem (Ms.)
FAKULTNI NEMOCNICE OSTRAVA
Czechia
EU contribution
€ 50 000
Address
17 Listopadu 1790
708 52 Ostrava Poruba
Activity type
Research Organisations
Administrative Contact
David Feltl (Dr.)
KRAJSKA NEMOCNICE T. BATI AS
Czechia
EU contribution
€ 50 000
Address
Havlickovo Nabrezi 600
76275 Zlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ladislava Martincová (Ms.)
ARTTIC
France
EU contribution
€ 126 705,57
Address
Rue Du Dessous Des Berges 58A
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Martin Dietz (Dr.)