Divorcio

|[pic] |THE DRIFT TRIAL |
| | |
| |Drainage, Irrigation and Fibrinolytic Therapy for  |
||Post-hemorrhagic Hydrocephalus for Newborn Infants |

         Trial Protocol Version 1.8 January 12th 2005 
Principal investigators :
Andrew Whitelaw, Professor of Neonatal Medicine, University of Bristol
Ian Pople, Consultant Paediatric Neurosurgeon, Frenchay Hospital, Bristol
Collaborators :
Dr David Evans, Consultant Neonatologist, SouthmeadHospital, Bristol
Dr Martin Simmonds, Consultant Neonatologist, Southmead Hospital, Bristol
Dr Neil Stoodley, Consultant Paediatric Neuroradiologist, Frenchay Hospital, Bristol
Dr Jolanta Wroblewska, Neonatologist, Upper Silesian Maternal and Child Health Centre, Katowice, Poland
Dr Marek Mandera, Paediatric Neurosugeon, Upper Silesian Maternal and Child Health Centre, Katowice,  Poland
Prof JanushSwietlinski, Neonatologist, Upper Silesian Maternal and Child Health Centre, Katowice, Poland
Dr Eva Swietlinska, Neonatologist, Upper Silesian Maternal and Child Health Centre, Katowice, Poland
Dr Judith Simpson, Consultant Neonatologist, Queen Mother's Hospital, Yorkhill, Glasgow 
Mr Robert Carachi, Consultant Paediatric Surgeon, Royal Hospital for Sick Children, Glasgow
Dr Andrew Watt,Consultant Paediatric Radiologist, Royal Hospital for Sick Children, Glasgow
Mr Alasdair Fyfe, Consultant Paediatric Surgeon, Royal Hospital for Sick Children, Glasgow
Mr Constantinos Hajivassiliou, Consultant Paediatric Surgeon, Royal Hospital for Sick Children, Glasgow
Statistical adviser: Dr Linda Hunt, Clinical Science at South Bristol, University of Bristol.

Corresponding author:Professor Andrew Whitelaw Neonatal Medicine Clinical Science at North Bristol University of Bristol Medical School
Southmead Hospital
BRISTOL BS10 5NB.

Contents :

|Introduction |Pilot data |Hypotheses |
|Inclusion / Exclusion criteria |Diagnostic methods |Randomisation|
|DRIFT Treatment |Surgical Procedure |Conventional Treatment |
|Information for parents |Follow-up |Statistical analyses |
|References | ||

Introduction
Hemorrhage into the ventricles of the brain is one of the most serious complications of premature birth despite improvements in the survival of premature infants. Large intraventricular hemorrhage (IVH) has a high risk of neurological disability and over 50 % of these children go on to develop progressive ventricular dilatation1. Murphy et al 2 have providedevidence that posthemorrhagic ventricular dilatation (PHVD) in the 1990s has a more aggressive course than previously with appreciable mortality and morbidity in extremely premature infants. Treatment is much more difficult than other types of hydrocephalus because the large amount of blood in the ventricle combined with the small size and instability of the patient make an earlyventriculoperitoneal shunt operation impossible. A period of repeated lumbar or ventricular reservoir tapping may be followed after many weeks by shunt surgery. There is a considerable complication rate from such surgery and the child is permanently dependent on the shunt system. Treatment by repeated lumbar or ventricular tapping and the use of acetazolamide and furosemide to reduce CSF production do not...