Physiologic measurements using continuous neonatal blood gas monitoring in preterm infants requiring mechanical ventilation for respiratory failure

ISRCTN	ISRCTN64017166
DOI	https://doi.org/10.1186/ISRCTN64017166
Protocol serial number	N0227165397
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	South Tees Hospitals NHS Trust, The James Cook University Hospital, NHS R&D Support Funding

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 K Lal
Scientific

South Tees Hospital Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	+44 (0)1642 282724
Email	Mithilesh.lal@stees.nhs.uk

Primary study design	Interventional
Study design	Single centre randomised crossover clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Variability in arterial PsO2 and PaCO2 as measured continuously by multiparameter arterial sensor (NeotrendR) in babies on different modes of mechanical ventilation.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal Diseases
Intervention	Single-centre randomised crossover clinical trial. Updated 27/01/2014: This trial was stopped because the manufacturers of the Neotrend/Paratrend device used for continuous blood gas monitoring went out of business and the product was no longer available.
Intervention type	Other
Primary outcome measure(s)	Coefficient of variation in blood gases (PaO2 and PaC02) while receiving mechanical ventilation.
Key secondary outcome measure(s)	Incidental physiological data that are routinely collected in babies requiring intensive care, such as core temperature, arterial PH.
Completion date	31/12/2006
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	10
Key inclusion criteria	Preterm newborn infants < 34 weeks gestation, requiring mechanical ventilation for respiratory failure.
Key exclusion criteria	All babies not receiving mechanical ventilation for respiratory failure.
Date of first enrolment	01/06/2005
Date of final enrolment	31/12/2006

South Tees Hospital Trust

Middlesbrough
TS4 3BW
United Kingdom

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