The Drainage, Irrigation and Fibrinolytic Trial for post-haemorrhagic hydrocephalus in newborn infants

ISRCTN	ISRCTN80286058
DOI	https://doi.org/10.1186/ISRCTN80286058
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Prof Andrew Whitelaw
Scientific

Neonatal Medicine
University of Bristol Medical School
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Phone	+44 (0)117 959 5699
Email	andrew.whitelaw@bristol.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The Drainage, Irrigation and Fibrinolytic Trial for post-haemorrhagic hydrocephalus in newborn infants: a randomised controlled trial
Study 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(s)	Southmead Local Research Ethics Committee, 28/01/2003, ref: 134/02
Condition	Post-haemorrhagic ventricular dilatation
Intervention	Drainage, irrigation and fibrinolytic therapy versus best standard therapy
Intervention type	Mixed
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 study start date	01/02/2003
Overall study end date	28/02/2009

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	120
Total final enrolment	77
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 exclusion criteria	Generalised bleeding tendency
Recruitment start date	01/02/2003
Recruitment end date	31/12/2006

University of Bristol Medical School

Bristol
BS10 5NB
United Kingdom

North Bristol NHS Trust (UK)
Hospital/treatment centre

Frenchay Hospital
Bristol
BS16 1LE
England
United Kingdom

Email	annette.clarke@nbt.nhs.uk
"ROR"	https://ror.org/036x6gt55

Charity

Cerebra (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

James and Grace Anderson Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	phase I trial results	01/04/2003		Yes	No
Other publications	short term outcomes	01/05/2007		Yes	No
Results article	results	01/04/2010		Yes	No
Results article	results	01/02/2019		Yes	No
Results article	10-year follow up results	04/07/2020	23/07/2020	Yes	No

23/07/2020: Publication reference added.
19/02/2019: Publication reference added.