Condition category
Neonatal Diseases
Date applied
01/09/2005
Date assigned
08/09/2005
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.neonatalneurology.org.uk

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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes