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Management of Hypotension In the Preterm Extremely Low Gestational Age Newborn

Objetivo

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

Ámbito científico

Programa(s)

Tema(s)

Convocatoria de propuestas

FP7-HEALTH-2010-single-stage
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Régimen de financiación

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

Coordinador

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK
Aportación de la UE
€ 1 296 306,00
Dirección
WESTERN ROAD
T12 YN60 Cork
Irlanda

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Región
Ireland Southern South-East
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
David O'connell (Dr.)
Enlaces
Coste total
Sin datos

Participantes (16)

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Última actualización: 25 Mayo 2022

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Permalink: https://cordis.europa.eu/project/id/260777/es

European Union, 2024