DRIFT10

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The DRIFT10 study has been set up to examine the effects of surgical drainage, irrigation and fibrinolytic therapy (DRIFT) in preterm infants with post-haemorrhagic ventricular dilatation, focusing on brain function and structure at school age.

DRIFT was developed as a method of washing out the ventricles in the brain to clear the effects of bleeding.  The DRIFT randomised trial was conducted in 2003-2006.  The aim of the DRIFT10 study is to compare cognitive function, visual function, sensorimotor ability and emotional well-being between the children in the two treatment groups from the DRIFT trial at school age.

The study runs from September 2014 to May 2016.

Background

Despite a number of different approaches to therapy, no intervention has been objectively shown to improve outcome in post-haemorrhagic ventricular dilatation.  Drainage, irrigation and fibrinolytic therapy (DRIFT) was developed as a method of washing out the ventricles to clear the effects of the bleeding.

Baby undergoing DRIFT

Eligible babies were preterm who had sustained intraventricular haemorrhage which expanded cerebral ventricles over pre-determined limits. With parental consent, 54 babies were randomised in Bristol and a further 20 in Poland, to either DRIFT or standard therapy which consisted of fluid tapping to control excessive expansion.

Magnetic resonance (MR) brain imaging carried out at term age in 36 babies in the DRIFT trial and showed cerebral lesions and/or impaired brain growth in a large proportion of the infants.

‌‌Testing understanding and language at 2 years old

However, when neurodevelopment was assessed by “blinded” observers at 2 years, severe disability or death was significantly reduced in the DRIFT group.‌  There was a large reduction in severe learning difficulties from 59% to 31% in the DRIFT group compared to the standard treatment group.

Study group

The children in the DRIFT trial are a unique study group with well-documented serious brain injury substantially different from the previous studies of preterm infants, most of whom have not had severe brain injury of this nature.

Cognitive testing at 2 years is limited, and can be difficult in children with motor impairment therefore it is important to do more comprehensive testing at school age. 

Vision testing at school ageCerebral visual impairment concerns how the brain processes images and cannot be adequately tested at 2 years. Thus it is important to thoroughly assess vision including techniques that can detect and define cerebral visual impairment.

Combined with MR imaging, the visual and cognitive assessments at school age will allow us to assess to what extent the brain has remodelled and adapted to the previous injury and will enable us to see if some functions (i.e. vision or language) have “moved” from their normal locations.

This study may provide vital insights into how the brain repairs and adapts after injury from IVH in premature infants, enabling future refinement of treatments and might ultimately lead to a reduction in disabilities in children born prematurely, with a long-term cost saving to health and education services, and improved quality of life.  

Co-investigators

Professor Andrew Whitelaw, MD, FRCPCH, Professor of Neonatal Medicine, University of Bristol and University Hospitals Bristol NHS Foundation Trust

Dr David Odd, Consultant in Neonatal Medicine, Southmead NICU, North Bristol NHS Trust

Dr Sally Jary, Research Paediatric Physiotherapist, St Michael’s NICU, UHBristol NHS Foundation Trust

Professor William Hollingworth, Professor of Health Economics, School of Social and Community Medicine, University of Bristol

Dr Pete Blair, Reader in Medical Statistics, School of Social and Community Medicine, University of Bristol

Dr Cathy Williams, MD, FRCS, Senior Lecturer in Paediatric Opthalmology, , University of Bristol, University Hospitals Bristol NHS Foundation Trust and North Bristol NHS Trust

Dr Michelle Morgan PhD, Clinical Child Psychologist, North Bristol NHS Trust

Dr Grazyna Kmita, Clinical Child Psychologist, Faculty of Psychology, University of Warsaw

Mr Ian Pople, Consultant Paediatric Neurosurgeon, North Bristol NHS Trust

Mr Kristian Aquilina, Consultant Paediatric Neurosurgeon, Great Ormond Street Hospital for Children NHS Trust

Mr Steve Walker-Cox, PPI Advisor and Parent.

Information for participants

How do I find CRICBristol?

Funded by the National Institute of Health Research (NIHR) Health Technology Assessment Programme

Contact

Chief Investigator:
Dr Karen Luyt
Consultant in Neonatal Medicine/Senior Lecturer
Neonatal Neuroscience and NICU
School of Clinical Sciences
University of Bristol
St Michael’s Hospital
Bristol BS2 8EG

Tel: +44 (0) 117 342 5439
Email: Karen.Luyt@bristol.ac.uk

Trial Coordinator and Study Contact:
Dr Sally Jary
DRIFT 10 Study Office
Neonatal Neurosciences
School of Clinical Sciences
University of Bristol
Level D, St Michael's Hospital
Bristol BS2 8EG

Tel: +44 (0) 117 34 25293
Email: Sally.Jary@bristol.ac.uk

Study Sponsor:
Dr Birgit Whitman
University of Bristol
Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol BS8 1TH

Tel: (0117) 331 7130
Email: birgit.whitman@bristol.ac.uk

Department of Health Disclaimer: The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.

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