Condition category
Neonatal Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
06/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.innovo-trial.org.uk

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes