Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Andrew Whitelaw
ORCID ID
Contact details
Neonatal Medicine
University of Bristol Medical School
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 959 5699
andrew.whitelaw@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The Drainage, Irrigation and Fibrinolytic Trial for post-haemorrhagic hydrocephalus in newborn infants: a randomised controlled trial
Acronym
DRIFT
Study hypothesis
In infants with post-haemorrhagic ventricular dilatation, treatment by drainage, irrigation and fibrinolytic therapy reduces ventriculoperitoneal shunt surgery and disability at 2 years when compared to best standard therapy.
On 11/02/2009 the following changes were made to the trial record:
1. The overall trial start date was changed from 28/02/2003 to 01/02/2003.
2. The overall trial end date was changed from 30/06/2009 to 28/02/2009.
Ethics approval
Southmead Local Research Ethics Committee, 28/01/2003, ref: 134/02
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Post-haemorrhagic ventricular dilatation
Intervention
Drainage, irrigation and fibrinolytic therapy versus best standard therapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Ventriculoperitoneal shunt surgery
2. Disability at 2 years post-term
Secondary outcome measures
1. Secondary haemorrhage
2. Secondary central nervous system (CNS) infection
3. Death before 2 years post-term
4. Hospital admissions by 2 years of age
Overall trial start date
01/02/2003
Overall trial end date
28/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Infants of less than 28 days of age
2. Intraventricular haemorrhage
3. Progressive enlargement of ventricles to 4 mm over the 97th centile for width or 1 mm over the 97th centile for diagnonal, thalamo-occipital and third ventricle or enlargement of one ventricle together with midline shift
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
120
Participant exclusion criteria
Generalised bleeding tendency
Recruitment start date
01/02/2003
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Norway, Poland, United Kingdom
Trial participating centre
University of Bristol Medical School
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
North Bristol NHS Trust (UK)
Sponsor details
Frenchay Hospital
Bristol
BS16 1LE
United Kingdom
-
annette.clarke@nbt.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cerebra (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Funder name
James and Grace Anderson Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2003 phase I trial results in: http://www.ncbi.nlm.nih.gov/pubmed/12671109
2. 2007 short term outcomes in: http://www.ncbi.nlm.nih.gov/pubmed/17403819
3. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20211949
Publication citations
-
Phase I trial results
Whitelaw A, Pople I, Cherian S, Evans D, Thoresen M, Phase 1 trial of prevention of hydrocephalus after intraventricular hemorrhage in newborn infants by drainage, irrigation, and fibrinolytic therapy., Pediatrics, 2003, 111, 4 Pt 1, 759-765.
-
Short term outcomes
Whitelaw A, Evans D, Carter M, Thoresen M, Wroblewska J, Mandera M, Swietlinski J, Simpson J, Hajivassiliou C, Hunt LP, Pople I, Randomized clinical trial of prevention of hydrocephalus after intraventricular hemorrhage in preterm infants: brain-washing versus tapping fluid., Pediatrics, 2007, 119, 5, e1071-8, doi: 10.1542/peds.2006-2841.
-
Results
Whitelaw A, Jary S, Kmita G, Wroblewska J, Musialik-Swietlinska E, Mandera M, Hunt L, Carter M, Pople I, Randomized trial of drainage, irrigation and fibrinolytic therapy for premature infants with posthemorrhagic ventricular dilatation: developmental outcome at 2 years., Pediatrics, 2010, 125, 4, e852-8, doi: 10.1542/peds.2009-1960.