Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012128264
Study information
Scientific title
Acronym
Study hypothesis
Can Adenosine replace nitric oxide in the treatment of PPHN?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Neonatal Diseases: Persistant pulmonary hypertension
Intervention
1. Intravenous adenosine
2. No adenosine
Intervention type
Drug
Phase
Not Specified
Drug names
Adenosine
Primary outcome measures
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 trial start date
01/12/2002
Overall trial end date
30/11/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Neonates with PPHN requiring mechanical ventilation and inhaled nitric oxide at 20 parts per million
Participant type
Patient
Age group
Neonate
Gender
Not Specified
Target number of participants
9
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2002
Recruitment end date
30/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
PICU
London
WC1N 3JH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Great Ormond Street Hospital for Children NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Institute of Child Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14697102
Publication citations
-
Results
Ng C, Franklin O, Vaidya M, Pierce C, Petros A, Adenosine infusion for the management of persistent pulmonary hypertension of the newborn., Pediatr Crit Care Med, 2004, 5, 1, 10-13, doi: 10.1097/01.CCM.0000105309.27519.27.