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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
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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)

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KATHOLIEKE UNIVERSITEIT LEUVEN

Belgium

EU Contribution

€ 483 936,30

UNIVERZITA KARLOVA

Czechia

EU Contribution

€ 208 872

CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE

Canada

EU Contribution

€ 243 375,75

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN

Ireland

EU Contribution

€ 179 087

THE COOMBE LYING-IN HOSPITAL

Ireland

EU Contribution

€ 438 738,30

CLININFO SA

France

EU Contribution

€ 67 575

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 100 000

BREPCO BIOPHARMA LTD

Ireland

EU Contribution

€ 888 000

GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Germany

EU Contribution

€ 305 004,43

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 511 500

THE GOVERNORS OF THE UNIVERSITY OF ALBERTA UNIVERSITY OF ALBERTA

Canada

EU Contribution

€ 183 586,50

ROYAL COLLEGE OF SURGEONS IN IRELAND

Ireland

EU Contribution

€ 162 635,40

UNIVERSITAIR ZIEKENHUIS ANTWERPEN

Belgium

EU Contribution

€ 60 000

FAKULTNI NEMOCNICE OSTRAVA

Czechia

EU Contribution

€ 50 000

KRAJSKA NEMOCNICE T. BATI AS

Czechia

EU Contribution

€ 50 000

ARTTIC

France

EU Contribution

€ 126 705,57

Project information

Grant agreement ID: 260777

Status

Closed project

  • Start date

    1 October 2010

  • End date

    30 September 2017

Funded under:

FP7-HEALTH

  • Overall budget:

    € 6 951 616,44

  • EU contribution

    € 5 355 322,25

Coordinated by:

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK

Ireland