|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
12 September 2022 |
|
Main ID: |
ISRCTN17821339 |
|
Date of registration:
|
25/10/2000 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a 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 |
|
Date of first enrolment:
|
01/02/1997 |
|
Target sample size:
|
160 |
|
Recruitment status: |
Completed |
|
URL:
|
https://www.isrctn.com/ISRCTN17821339 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomised controlled trial (Treatment)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
England
|
Ireland
|
United Kingdom
| | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Diana
Elbourne |
|
Address:
|
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
WC1E 7HT
London
United Kingdom |
|
Telephone:
|
+44 (0)20 7927 2629 |
|
Email:
|
diana.elbourne@lshtm.ac.uk |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Respiratory disease
Neonatal Diseases
Respiratory failure
|
|
Intervention(s)
|
|
Nitric oxide/control
|
|
Primary Outcome(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
|
|
Secondary Outcome(s)
|
|
Not provided at time of registration
|
|
Source(s) of Monetary Support
|
|
Medical Research Council (UK)
|
|
Ethics review
|
Status:
Approval date:
Contact:
Not provided at time of registration
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/07/2005 |
|
URL:
|
|
|
|