To evaluate whether intravenous Adenosine would replace the need for inhaled nitric oxide (iNO) in the management of Persistent Pulmonary Hypertension of the Newborn (PPHN)
| ISRCTN | ISRCTN51768118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51768118 |
| Secondary identifying numbers | N0012128264 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 08/07/2009
- 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
Dr CM Pierce
Scientific
Scientific
PICU
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 | |
| Study objectives | Can Adenosine replace nitric oxide in the treatment of PPHN? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Persistant pulmonary hypertension |
| Intervention | 1. Intravenous adenosine 2. No adenosine |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Adenosine |
| Primary outcome measure | Whether Adenosine can replace or supplement the use of iNO in the treatment of PPHN. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2002 |
| Completion date | 30/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 9 |
| Key inclusion criteria | Neonates with PPHN requiring mechanical ventilation and inhaled nitric oxide at 20 parts per million |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/12/2002 |
| Date of final enrolment | 30/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
PICU
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
Hospital/treatment centre
Great Ormond Street Hospital for Children NHS Trust (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2004 | Yes | No |
