Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Diana Elbourne
ORCID ID
Contact details
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2629
diana.elbourne@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9608436
Study information
Scientific title
Acronym
The INNOVO Trial
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Respiratory disease
Intervention
Nitric oxide/control
Intervention type
Drug
Phase
Not Applicable
Drug names
Inhaled nitric oxide (INO)
Primary outcome measure
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/1997
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
160
Participant exclusion criteria
Does not comply with above criteria
Recruitment start date
01/02/1997
Recruitment end date
31/07/2005
Locations
Countries of recruitment
Ireland, United Kingdom
Trial participating centre
Medical Statistics Unit
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
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)
Publication citations
-
Field D, Elbourne D, Truesdale A, Grieve R, Hardy P, Fenton AC, Subhedar N, Ahluwalia J, Halliday HL, Stocks J, Tomlin K, Normand C, , Neonatal Ventilation With Inhaled Nitric Oxide Versus Ventilatory Support Without Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure: the INNOVO multicentre randomised controlled trial (ISRCTN 17821339)., Pediatrics, 2005, 115, 4, 926-936, doi: 10.1542/peds.2004-1209.
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Field D, Elbourne D, Hardy P, Fenton AC, Ahluwalia J, Halliday HL, Subhedar N, Heinonen K, Aikio O, Grieve R, Truesdale A, Tomlin K, Normand C, Stocks J, , Neonatal ventilation with inhaled nitric oxide vs. ventilatory support without inhaled nitric oxide for infants with severe respiratory failure born at or near term: the INNOVO multicentre randomised controlled trial., Neonatology, 2007, 91, 2, 73-82, doi: 10.1159/000097123.
-
Huddy CL, Bennett CC, Hardy P, Field D, Elbourne D, Grieve R, Truesdale A, Diallo K, , The INNOVO multicentre randomised controlled trial: neonatal ventilation with inhaled nitric oxide versus ventilatory support without nitric oxide for severe respiratory failure in preterm infants: follow up at 4-5 years., Arch. Dis. Child. Fetal Neonatal Ed., 2008, 93, 6, F430-5, doi: 10.1136/adc.2007.129353.