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ISRCTN
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ISRCTN17821339
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DOI
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10.1186/ISRCTN17821339
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a randomised controlled trial
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Scientific title
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Acronym
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The INNOVO Trial
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Serial number at source
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G9608436
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Study hypothesis
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Although inhaled nitric oxide (INO) may be a promising treatment for newborn infants with severe respiratory failure, the results from three previous small trials were inconclusive. The objectives are:
1. To assess the clinical effectiveness and cost effectiveness of a policy of adding or not adding inhaled nitric oxide (INO) to the ventilator gases of neonates with severe respiratory failure
2. To conduct relevant sub-studies
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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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Ireland, United Kingdom
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Disease/condition/study domain
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Respiratory disease
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Participants - inclusion criteria
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1. Respiratory failure requiring ventilatory support
2. Less than 28 days old
3. No evidence of uncorrected bleeding disorder
4. No ultrasound evidence of intraparenchymal lesions
5. No contra-indication to continuation of treatment, known at trial entry
6. Informed assent of the parent(s) following discussion and written information
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Participants - exclusion criteria
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Does not comply with above criteria
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Anticipated start date
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01/02/1997
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Anticipated end date
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31/07/2005
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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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160
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Interventions
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Nitric oxide/control
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Primary outcome measure(s)
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1. To conduct relevant sub-studies
2. Death
3. Severe disability at 1 year of age (corrected)
4. Chronic lung disease, defined as being on supplemental oxygen at the expected date of delivery (preterm stratum) and at 28 days post delivery ('mature stratum')
5. Length of time on supplemental oxygen
6. Costs
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Secondary outcome measure(s)
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Not provided at time of registration
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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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http://www.innovo-trial.org.uk
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Publications
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Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/15805366
2. http://www.ncbi.nlm.nih.gov/pubmed/17344656
3. http://www.ncbi.nlm.nih.gov/pubmed/18375612 (4 - 5 year follow-up results)
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Contact name
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Prof
Diana
Elbourne
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Address
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Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7927 2629
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Fax
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+44 (0)20 7637 2853
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Email
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diana.elbourne@lshtm.ac.uk
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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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06/08/2008
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Date ISRCTN assigned
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25/10/2000
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