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
Protocol serial number	G9608436
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Diana Elbourne
Scientific

Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2629
Email	diana.elbourne@lshtm.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Inhaled nitric oxide (INO)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2005

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Medical Statistics Unit

London
WC1E 7HT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

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
Study website	Study website	11/11/2025	11/11/2025	No	Yes

01/09/2022: Internal review.