Randomised controlled trials and feasibility studies for newer modes of artificial ventilation in newborns with respiratory failure

ISRCTN	ISRCTN40254851
DOI	https://doi.org/10.1186/ISRCTN40254851
Secondary identifying numbers	N0227097989

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Sunil Sinha
Scientific

Women & Children Division
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	+44 (0)1642 854874
Email	s.k.sinha@ncl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	To assess the efficacy and safety of these newer modes of artificial ventilation, and assess their superiority over conventional ventilation in terms of mortality, analysis of cost of treatment, and short and long term respiratory outcome.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory failure
Intervention	Randomised controlled trial of different modes of ventilation. Patients were randomised to different modes of ventilation, or the conventional ventilation methods.
Intervention type	Other
Primary outcome measure	Duration of ventilation and weaning
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/01/1999
Completion date	31/07/2004

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target number of participants	100
Key inclusion criteria	Babies less than 1500 g with respiratory distress syndrome (RDS) requiring ventilation
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1999
Date of final enrolment	31/07/2004

Women & Children Division

Middlesbrough
TS4 3BW
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

South Tees Hospitals NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006	Yes	No
Results article	results	01/03/2007	Yes	No
Results article	results	01/03/2009	Yes	No
Results article	results	01/09/2009	Yes	No