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

ISRCTN	ISRCTN96341949
DOI	https://doi.org/10.1186/ISRCTN96341949
Protocol serial number	N0012134105
Sponsor	Department of Health
Funder	Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr M Montgomery
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Safety and efficacy study of a nitric oxide generating system for neonatal cannulation
Study objectives	The use of a nitric oxide generating system applied to the skin increases the success of long line placement in neonates.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal Diseases: Cannulation
Intervention	1. Nitric oxide for neonatal cannulation 2. No nitric oxide
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Nitric oxide
Primary outcome measure(s)	Increased success in percutaneous long line placement in neonates
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2005

Participant type(s)	Patient
Age group	Neonate
Sex	All
Key inclusion criteria	Neonates presenting to neonatal intensive care unit (NICU)
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2003
Date of final enrolment	30/04/2005

Great Ormond Street Hospital

London
WC1N 3JH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan