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

Not Applicable

Completed

• Conditions: Respiratory disease; Neonatal Diseases; Respiratory failure

• Registration Number: ISRCTN17821339
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

2005 Results article in http://www.ncbi.nlm.nih.gov/pubmed/15805366 2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17344656 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18375612

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-10-25
• Study Completion: 2005-07-31
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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

Exclusion Criteria

Does not comply with above criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. To conduct relevant sub-studies<br> 2. Death<br> 3. Severe disability at 1 year of age (corrected)<br> 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')<br> 5. Length of time on supplemental oxygen<br> 6. Costs<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration