Safety and efficacy study of a nitric oxide generating system for neonatal cannulation
| ISRCTN | ISRCTN96341949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96341949 |
| Secondary identifying numbers | N0012134105 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Montgomery
Scientific
Scientific
Cardiothoracic
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
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 | Safety and efficacy study of a nitric oxide generating system for neonatal cannulation |
| Study objectives | The use of a nitric oxide generating system applied to the skin increases the success of long line placement in neonates. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Cannulation |
| Intervention | 1. Nitric oxide for neonatal cannulation 2. No nitric oxide |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nitric oxide |
| Primary outcome measure | Increased success in percutaneous long line placement in neonates |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Neonates presenting to neonatal intensive care unit (NICU) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (UK)
No information available
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 |
