Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a randomised controlled trial
| ISRCTN | ISRCTN17821339 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17821339 |
| Secondary identifying numbers | G9608436 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 01/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Diana Elbourne
Scientific
Scientific
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7927 2629 |
|---|---|
| diana.elbourne@lshtm.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a randomised controlled trial |
| Study acronym | The INNOVO Trial |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 160 |
| Key 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 |
| Key exclusion criteria | Does not comply with above criteria |
| Date of first enrolment | 01/02/1997 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
Medical Statistics Unit
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2005 | Yes | No | ||
| Results article | 01/04/2007 | Yes | No | ||
| Results article | 01/11/2008 | Yes | No |
Editorial Notes
01/09/2022: Internal review.
