Use of high frequency oscillatory ventilation for the prevention of chronic lung disease of prematurity: a multicentre trial

ISRCTN	ISRCTN98436149
DOI	https://doi.org/10.1186/ISRCTN98436149
Secondary identifying numbers	G9700481

Submission date: 25/10/2000
Registration date: 25/10/2000
Last edited: 30/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sandra Calvert
Scientific

Department of Child Health
St George's Hospital Medical School
Cranmer Terrace
London
SW17 0RE
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	1.To determine whether early intervention with high frequency oscillatory ventilation (HFOV) reduces the incidence of chronic lung disease (CLD), defined as a persistent oxygen requirement at a corrected gestational age of 36 weeks, in preterm infants born at less than 29 weeks gestation. 2.To ensure that any short term benefits of HFOV are not associated with an increase in subsequent respiratory or neurological morbidity
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic lung disease
Intervention	1. Early intervention with high frequency oscillatory ventilation (HFOV) 2. Control
Intervention type	Other
Primary outcome measure	Composite variable: 1. Death before discharge from neonatal services 2. Chronic lung disease, defined as oxygen dependency 36 weeks post menstrual age (PMA)
Secondary outcome measures	1. Age at death 2. Age at final extubation 3. Failure of treatment 4. Abnormal cerebral ultrasound 5. Postnatal use of systematic steroids 6. Hearing loss greater than 60 dB 7. Pneumothorax 8. Age finally out of oxygen 9. Pulmonary haemorrhage 10. Patent ductus arteriosus 11. Retinopathy of prematurity 12. Age at discharge from hospital Long-term outcome measures: 1. Respiratory morbidity over the first two years 2. Presence of disability at two years
Overall study start date	26/01/1998
Completion date	25/10/2003

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	800
Key inclusion criteria	1. Gestational age less than 29 weeks 2. Require endotracheal ventilation 3. It is considered appropriate that intensive care is continued 4. No identified major congenital malformation
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	26/01/1998
Date of final enrolment	25/10/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Child Health

London
SW17 0RE
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/08/2002		Yes	No
Results article	results	01/06/2014		Yes	No