Wspólnotowy Serwis Informacyjny Badan i Rozwoju - CORDIS

FP7

THE HIP TRIAL Streszczenie raportu

Project ID: 260777
Źródło dofinansowania: FP7-HEALTH
Kraj: Ireland

Periodic Report Summary 2 - THE HIP TRIAL (Management of Hypotension In the Preterm Extremely Low Gestational Age Newborn)



Project Context and Objectives:

A more observational approach to the management of hypotension in the preterm extremely low gestational age newborn infant (ELGAN) will result in a reduction in the incidence of death or severe cranial ultrasound abnormality at 36 weeks gestational age.

Primary Objective:

Our primary objective is to determine whether a more observational approach to the diagnosis and management of hypotension compared to a standard approach, within the first 72 hrs of life (transitional period), 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.

Secondary Objectives:

Our secondary objectives are:

1. to determine whether a observational approach to the diagnosis and management of hypotension with dopamine as a first line inotrope, affects all cause mortality at 36 weeks gestational age;
2. to determine whether a observational approach, affects incidence of grade III-IV intraventricular haemorrhage or periventricular leukomalacia on cranial ultrasound; and finally
3. to determine whether inotrope use is associated with adverse treatment effects

Our tertiary objective is submission of a PUMA for dopamine in the older age group of paediatric populations.

Project Results:

WP01: A significant amount of progress has occurred over the last 18 months, including a revision of the original Annex which was submitted to the EC for consideration and approved and an application for Competent Authority approval has been submitted via the Voluntary Harmonisation Procedure. We have published a manuscript on The PDCO as a way of raising the awareness amongst health care personnel of and it provides the reader with a clear understanding of the process required to obtain a Paediatric Investigational Plan. We have also submitted our study protocol to “Neonatology”, having addressed their original questions, and have received positive feedback: “Neonatology” Neonatology accepted our manuscript for publication.

WP02: A number of training courses have taken place in the last 18 months. These have been coordinated by the WP02 lead, in conjunction with input from WP01, 04, 05, 06, 07, 08. There are now over 80 study personnel who are GCP trained. Videos of all these courses are readily available to study personnel through a password protected web link. Another training course was also held in Prague in November 2012.

WP03: The survey of practice has been completed and a report submitted. This has also been submitted for publication and is currently under review with the European Journal of Pediatrics.

WP04: The protocol, Informed Consent Form and Parent Information leaflet have undergone QC review which resulted in them being revised and updated. These will be made available online for the Investigators. Irish Ethics approval for the study was granted on 16th January 2013. CUNI has received ethics approval and the approval is pending for the other trial sites. The HIP consortium continues to prepare for the initiation of the clinical phase of the study, although delays have occurred as a result of the failure to develop a stable formulation of dopamine. Start date late Dec 2013, early Jan 2014.

WP05: A clinical trial monitor has been appointed and trial site initiation visits start in December 2013. The SOP on Pharmacovigilance is finalised.

Outcome Assessment (WP06, 07, 08, 09): A training workshop in ECHO, EEG and NIRS was held at the CWIUH (CR06) in February 2013. Members of all Irish and European participating centers attended the course. Training sessions were filmed and the material is available for internal use. A refresher session is planned after study commencement and enrollment of first patients. The SOP for Neurodevelopmental outcome in WP09 was finalised and the report on agreed outcome measures also is finalised.

WP10: SOP detailing the procedure for collection and processing of PK/PD samples at site level and transport of samples back to the analysis laboratory has been finalised and will be available to all sites in the coming weeks. We have been able to show that dopamine is now stable in solution at 3 months when frozen at -80C.

WP11: There have been 3 failed attempts over the last 18 months to develop a stable dopamine formulation which has led to a significant time delay in commencing the clinical trial. Thankfully the current stability testing has been a success. Also a report has been compiled on the use of dopamine in the older paediatric population and we hope to apply for a PUMA for dopamine in the older age group in the first 6 months of 2014.

WP12: Data management is in place, the eCRF is complete and training in the eCRF has been available to all study personnel over the last 18 months.

WP13: The topics for the 1st Amendment to the Annex I to the Grant Agreement were collated by GABO:mi in close collaboration with the Coordinator, just like other tasks such as communication management, project controlling, finance management or meeting organisation. WP02, 06, 07 08 have been supported with the organisation of workshop sessions in February 2013. GABO:mi has organised all HIP project meetings and video conferences to the highest standard. GABO:mi has also ensured that all partners are aware of any teleconferences, project meetings and international conferences and have been overseeing that each project partner is keeping up to date with their relevant milestones and deliverables.

WP14: This has been a complex process, involving the review of over 700 articles in total in an attempt to reach our objectives. The results are summarised, the Report is attached (see D14.01) and this forms the basis of a submission for a PUMA to the EMA on dopamine use in the older age group.

Potential Impact:

Expected final results:

Significant results for the second 18 months are detailed below:

 We have finalized the clinical trial protocol, Parent Information Leaflet, Informed Consent Form and 19 SOPs. The Investigator Brochure, the IMPD are final and along with other necessary trial documents have been submitted to the national competent authorities via the Voluntary Harmonisation Procedure. We expect approval from the VHP by December 2013.
 A trial monitor has been appointed with 10 years' experience in clinical trials. As a clinical research associate she is also responsible for Quality Control (QC) of all study documentation. All standard operating procedures, study logs and forms and trial protocol have been updated.
 A clinical trial application was made to the National Research Ethics Committee on 18th December 2012. The committee reviewed the application and Ethics approval was granted on 16th January 2013 for the Irish sites.
 PK/PD methodology has been finalized and a SOP has been drafted for the handling of sampling.
 Training workshops have taken place for ECHO, EEG and NIRS, GCP on Feb 2013 and Nov 2012
 Survey on the Diagnosis and Treatment of Hypotension in the Extremely Preterm Infant completed and submitted for publication.
 We have finalized our Pharmacovigilance SOP and appointed a Pharmacovigilance Officer.
 Two new sites have come on board, namely the Maternity Hospital in Belfast and the neonatal service at Antwerp, bringing expertise in clinical trials and echocardiography, and a significant number of patient population for enrollment.
 An online database (eCRF) has been developed and all sites have had access to it for training purposes for the past 6 months. This will be finalized shortly. A SOP for the database has been finalized.
 The HIP Trial website www.hip-trail.com has been updated continuously and now also reflects the current Annex I to the Grant Agreement approved by the European Commission on 29 May 2013.
 We have been awarded a PIP from the Pediatric Committee of the European Medicines Agency.
 Presentations of our research objective at a number of national and international meetings.
 Study Protocol accepted by “Neonatology” and forwarded for publication
 Publication relating to the PDCO

Potential impact and use

We expect that in the next 18 months the following goals for HIP will be achieved:

 The Clinical phase of the trial will begin in late December 2013/January 2014.
 We will provide the review of safety 6 months after the trial has begun dosing and another review 6 months after the first review. We do not expect any further delays to the trial.
 We have included two new trial sites of new sites which are currently being identified.
 Revised timelines of the planned Deliverables and Milestones in the Annex I to the Grant Agreement.
 PUMA submission to EMA for dopamine use in the older age Group

List of Websites:

www.hip-trial.com


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Reported by

UNIVERSITY COLLEGE CORK, NATIONAL UNIVERSITY OF IRELAND, CORK
Ireland
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