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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN67254766
Date of registration:	12/09/2003
Prospective Registration:	No
Primary sponsor:	Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Public title:	Optimising arterial carbon dioxide during initial stabilisation in ventilated newborn infants: a randomised controlled trial
Scientific title:
Date of first enrolment:	01/06/2000
Target sample size:	40
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN67254766
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Jagjit S Ahluwalia
Address:	Box No 226 Neonatal Intensive Care Unit The Rosie Hospital CB2 2QQ Cambridge United Kingdom
Telephone:	+44 (0)1223 367417
Email:	jag.ahluwalia@addenbrookes.nhs.uk
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 40 infants showing a 50% difference in the incidence of out of range in the first hour of life
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Neonatal Diseases: Artificial ventilation
Neonatal Diseases
Artificial ventilation

Intervention(s)

1. Synchronised Intermittent Postive Pressure Ventilation (SIPPV)
2. SIPPV plus Volume Guarantee

Infants requiring artificial ventilation will be entered in the trial following antenatal parental assent. Formal consent will be obtained within 24 h of birth. Study infants will be randomly assigned to either receive Synchronised Intermittent Positive Pressure Ventilation (SIPPV) or SIPPV plus Volume Guarantee (VG). The assigned mode of ventilation will continue until arterial access has been obtained and results of blood gas analysis are available. The infants will then continue on the clinician determined mode of ventilation.

Primary Outcome(s)

Not provided at time of registration

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

N0544093462

Source(s) of Monetary Support

Cambridge Consortium - Addenbrooke's Hospital NHS Foundation Trust (UK)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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