Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a randomised controlled trial

Plain English Summary

Not provided at time of registration

Study website

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

Type

Scientific

Contact name

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

G9608436

Scientific title

Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a randomised controlled trial

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(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Condition

Respiratory disease

Intervention

Nitric oxide/control

Intervention type

Drug

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

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 study start date

01/02/1997

Overall study end date

31/07/2005

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Neonate

Sex

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

Countries of recruitment

England, Ireland, United Kingdom

Study participating centre

Medical Statistics Unit
London
WC1E 7HT
United Kingdom

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

http://www.mrc.ac.uk

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

UK Medical Research Council, MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

Not provided at time of registration

IPD sharing plan summary

Not provided at time of registration

Study outputs