Collaborative randomised controlled trial of trigger versus conventional ventilation in preterm infants with respiratory distress syndrome

ISRCTN ISRCTN53727120
DOI https://doi.org/10.1186/ISRCTN53727120
Secondary identifying numbers C/6/16-04-94/BAUMER/F
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
09/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Harry Baumer
Scientific

Plymouth Hospitals NHS Trust
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Phone +44 (0)1752 763450
Email harry.baumer@phnt.swest.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesObjectives: To investigate the effects of Patient Triggered Ventilation (PTV) compared with conventional ventilation (Intermittent Mandatory Ventilation [IMV]) in preterm infants ventilated for Respiratory Distress Syndrome (RDS).

Setting: Twenty-two neonatal intensive care units.

Design: Subjects were 924 babies under 32 weeks gestation and within 72 hours of birth ventilated for RDS for less than 6 hours. Telephone randomisation to receive either PTV or IMV. Analysis on "intention to treat" basis.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNeonatal diseases
Intervention1. Trigger ventilation
2. Conventional ventilation
Intervention typeOther
Primary outcome measure1. Death before discharge home or oxygen therapy at 36 weeks gestation
2. Pneumothorax whilst ventilated
3. Cerebral ultrasound abnormality nearest 6 weeks
4. Duration of ventilation in survivors
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/1994
Completion date31/03/1998

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants924
Key inclusion criteriaInfants of less than 32 weeks gestation, they are ventilated within 72 hours of birth, and have features compatible with respiratory distress syndrome
Key exclusion criteriaBabies with evidence of major congenital malformation or evidence of inhalational pneumonitis will be excluded
Date of first enrolment01/11/1994
Date of final enrolment31/03/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Plymouth Hospitals NHS Trust
Plymouth
PL6 8DH
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South West (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2000 Yes No