Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
08/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr CM Pierce

ORCID ID

Contact details

PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes