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 |
| Protocol serial number | N0012128264 |
| Sponsor | Department of Health |
| Funders | Great Ormond Street Hospital for Children NHS Trust (UK), Institute of Child Health (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Adenosine |
| Primary outcome measure(s) |
Whether Adenosine can replace or supplement the use of iNO in the treatment of PPHN. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
PICU
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
