Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/04/2015
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 M Montgomery

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0012134105

Study information

Scientific title

Safety and efficacy study of a nitric oxide generating system for neonatal cannulation

Acronym

Study hypothesis

The use of a nitric oxide generating system applied to the skin increases the success of long line placement in neonates.

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: Cannulation

Intervention

1. Nitric oxide for neonatal cannulation
2. No nitric oxide

Intervention type

Drug

Phase

Not Applicable

Drug names

Nitric oxide

Primary outcome measures

Increased success in percutaneous long line placement in neonates

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2003

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Neonates presenting to neonatal intensive care unit (NICU)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2003

Recruitment end date

30/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Great Ormond Street Hospital
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

Government

Funder name

Great Ormond Street Hospital for Children NHS Trust/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

Publication citations

Additional files

Editorial Notes