THE HIP TRIAL

Management of Hypotension In the Preterm Extremely Low Gestational Age Newborn

 Coordinatore UNIVERSITY COLLEGE CORK, NATIONAL UNIVERSITY OF IRELAND, CORK 

 Organization address address: Western Road
city: CORK
postcode: -

contact info
Titolo: Dr.
Nome: David
Cognome: O'connell
Email: send email
Telefono: +353 21 4902347
Fax: +353 21 4920770

 Nazionalità Coordinatore Ireland [IE]
 Totale costo 7˙359˙530 €
 EC contributo 5˙662˙043 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2010-single-stage
 Funding Scheme CP-FP
 Anno di inizio 2010
 Periodo (anno-mese-giorno) 2010-10-01   -   2015-09-30

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    UNIVERSITY COLLEGE CORK, NATIONAL UNIVERSITY OF IRELAND, CORK

 Organization address address: Western Road
city: CORK
postcode: -

contact info
Titolo: Dr.
Nome: David
Cognome: O'connell
Email: send email
Telefono: +353 21 4902347
Fax: +353 21 4920770

IE (CORK) coordinator 1˙296˙306.00
2    BREPCO BIOPHARMA LTD

 Organization address address: "Suite One, The Avenue, Beacon Court, Sandyford"
city: Dublin
postcode: D18

contact info
Titolo: Mr.
Nome: Seamus
Cognome: Oloan
Email: send email
Telefono: +1 4849198089
Fax: +353 1 2949400

IE (Dublin) participant 738˙000.00
3    KATHOLIEKE UNIVERSITEIT LEUVEN

 Organization address address: Oude Markt 13
city: LEUVEN
postcode: 3000

contact info
Titolo: Dr.
Nome: Elke
Cognome: Lammertyn
Email: send email
Telefono: +32 16 320621
Fax: +32 16 326515

BE (LEUVEN) participant 537˙707.00
4    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)

 Organization address address: 101 Rue de Tolbiac
city: PARIS
postcode: 75654

contact info
Titolo: Mr.
Nome: Nicolas
Cognome: Jeanjean
Email: send email
Telefono: +33 1 4078 4900
Fax: +33 1 4078 4998

FR (PARIS) participant 511˙500.00
5    THE COOMBE LYING-IN HOSPITAL

 Organization address address: DOLPHINS BARN CORK STREET
city: Dublin
postcode: Dublin 8

contact info
Titolo: Mr.
Nome: Patrick
Cognome: Donohue
Email: send email
Telefono: +353 1408 5299

IE (Dublin) participant 487˙487.00
6    UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN

 Organization address address: BELFIELD
city: DUBLIN
postcode: 4

contact info
Titolo: Mr.
Nome: Donal
Cognome: Doolan
Email: send email
Telefono: +353 1 716 1656
Fax: +353 1 716 1216

IE (DUBLIN) participant 379˙087.00
7    GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG GAB O

 Organization address address: Oskar-von-Miller-Ring 29
city: MUENCHEN
postcode: 80333

contact info
Titolo: Ms.
Nome: Birgit
Cognome: Fuchs
Email: send email
Telefono: +49 89 288104 14
Fax: +49 89 288104 20

DE (MUENCHEN) participant 370˙800.00
8    CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE

 Organization address address: COTE SAINTE CATHERINE 3175 ETAGE C BLOC 5
city: MONTREAL QUEBEC
postcode: H3T 1C5

contact info
Titolo: Dr.
Nome: Jean
Cognome: Langlais
Email: send email
Telefono: +1 514 345 4931
Fax: +1 514 345 4698

CA (MONTREAL QUEBEC) participant 256˙185.00
9    UNIVERSITY COLLEGE LONDON

 Organization address address: GOWER STREET
city: LONDON
postcode: WC1E 6BT

contact info
Titolo: Ms.
Nome: Greta
Cognome: Borg-Carbott
Email: send email
Telefono: +44 20 3108 3033
Fax: +44 20 78132849

UK (LONDON) participant 246˙625.00
10    UNIVERZITA KARLOVA V PRAZE

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

contact info
Titolo: Mr.
Nome: Jaromír
Cognome: Chlapec
Email: send email
Telefono: +420 267 102 260
Fax: +420 267 311 812

CZ (PRAHA 1) participant 232˙080.00
11    UNIVERSITY OF ALBERTA

 Organization address address: 114 ST - 89 AVE
city: "EDMONTON, ALBERTA"
postcode: T6G 2E1

contact info
Titolo: Ms.
Nome: Lorraine
Cognome: Deydey
Email: send email
Telefono: +1 780 492 6282
Fax: +1 780 492 0949

CA ("EDMONTON, ALBERTA") participant 203˙985.00
12    ROYAL COLLEGE OF SURGEONS IN IRELAND

 Organization address address: Saint Stephen's Green 123
city: DUBLIN
postcode: 2

contact info
Titolo: Mr.
Nome: Barry
Cognome: Mcgowan
Email: send email
Telefono: +353 1 4022478
Fax: +353 1 4022478

IE (DUBLIN) participant 180˙706.00
13    CLININFO S.A.

 Organization address address: RUE DE GERLAND- ENTREE 7 99
city: LYON
postcode: 69007

contact info
Titolo: Mr.
Nome: Patrick
Cognome: Chevarier
Email: send email
Telefono: +33 478 614 426
Fax: +33 478 583 167

FR (LYON) participant 61˙575.00
14    UNIVERSITAIR ZIEKENHUIS ANTWERPEN

 Organization address address: WILRIJKSTRAAT 10
city: EDEGEM
postcode: 2650

contact info
Titolo: Ms.
Nome: Daisy
Cognome: Van Mieghem
Email: send email
Telefono: +32 38213191

BE (EDEGEM) participant 60˙000.00
15    FAKULTNI NEMOCNICE S POLIKLINIKOU OSTRAVA FOUNDATION

 Organization address address: 17 LISTOPADU 1790
city: OSTRAVA PORUBA
postcode: 708 52

contact info
Titolo: Dr.
Nome: David
Cognome: Feltl
Email: send email
Telefono: 420597000000

CZ (OSTRAVA PORUBA) participant 50˙000.00
16    KRAJSKA NEMOCNICE T. BATI AS

 Organization address address: Havlickovo nabrezi 600
city: Zlin
postcode: 76275

contact info
Titolo: Ms.
Nome: Ladislava
Cognome: Martincová
Email: send email
Telefono: +420 577 522 260

CZ (Zlin) participant 50˙000.00

Mappa


 Word cloud

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

infants    hypotension    flow    impaired    treatment    impact    age    newborn    born    evidence    dopamine    clinical    cerebral    neonatal    implications    blood    injury    affects    extremely    practices    brain    outcome    preterm    criteria    diagnosis    inotropic    disability    weeks    pressure    approximately    perform    inotrope    gestational    hip    newborns    trial    survival   

 Obiettivo del progetto (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'

Descrizione progetto (Article)

Hypotension is considered to be responsible for inadequate oxygen delivery to the organs, leading to impaired cerebral blood flow, cerebral ischaemia and brain injury. Although there are no clear criteria on the definition and long-term impact of hypotension, current clinical management entails treatment for this pathology with inotropic drugs (e.g.dopamine). However, preterm infants treated for low blood pressure often show no signs of shock and may have normal systemic blood flow.

Members of the EU-funded 'Management of hypotension in the preterm extremely low gestational age newborn' (http://www.hip-trial.com (THE HIP TRIAL)) project propose to address this issue through a more observational approach without intervention. Retrospective analysis of a large neonatal database (CNN) has demonstrated that treatment of hypotension and not hypotension itself was associated with brain injury.

Given that current management measures are based on evidence from small studies, THE HIP TRIAL project is conducting a phase III randomised trial in order to evaluate the impact of dopamine for hypotension treatment. Clinical trial preparations are ongoing with considerable effort being devoted to finalising the actual protocol, Informed Consent Form and Parent Information leaflet.

A pan-European survey intended to collect information on current diagnosis and treatment practices has been completed. To advance existing practices and train clinical personnel, a series of training sessions and workshops have been planned and taken place. They focused on echocardiography, near-infrared spectroscopy and electroencephalography as means of diagnosis and of assessing blood pressure, cerebral activity and cardiovascular performance in preterm infants. Expert groups in these methodologies have been established and will be used during the clinical trial.

THE HIP TRIAL is the largest study conducted so far to address the impact of inotropic drug administration for treating hypotension in preterm infants. Since brain injury leads to lifelong disability, the outcome of the study holds great socioeconomic implications.

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