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ISRCTN
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ISRCTN98436149
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DOI
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10.1186/ISRCTN98436149
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Use of high frequency oscillatory ventilation for the prevention of chronic lung disease of prematurity: a multicentre trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9700481
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic lung disease
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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26/01/1998
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Anticipated end date
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25/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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800
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Interventions
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1. Early intervention with high frequency oscillatory ventilation (HFOV)
2. Control
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Primary outcome measure(s)
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Composite variable:
1. Death before discharge from neonatal services
2. Chronic lung disease, defined as oxygen dependency 36 weeks post menstrual age (PMA)
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Secondary outcome measure(s)
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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
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/pubmed/12200550
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Contact name
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Dr
Sandra
Calvert
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Address
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Department of Child Health
St George's Hospital Medical School
Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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31/03/2009
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Date ISRCTN assigned
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25/10/2000
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