Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.refer.nhs.uk/ViewRecord.asp?ID=193

Contact information

Type

Scientific

Primary contact

Dr Harry Baumer

ORCID ID

Contact details

Plymouth Hospitals NHS Trust
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
+44 (0)1752 763450
harry.baumer@phnt.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C/6/16-04-94/BAUMER/F

Study information

Scientific title

Acronym

Study hypothesis

Objectives: 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neonatal diseases

Intervention

1. Trigger ventilation
2. Conventional ventilation

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. 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 measures

Not provided at time of registration

Overall trial start date

01/11/1994

Overall trial end date

31/03/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Infants of less than 32 weeks gestation, they are ventilated within 72 hours of birth, and have features compatible with respiratory distress syndrome

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

924

Participant exclusion criteria

Babies with evidence of major congenital malformation or evidence of inhalational pneumonitis will be excluded

Recruitment start date

01/11/1994

Recruitment end date

31/03/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Plymouth Hospitals NHS Trust
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2000 results in: http://www.ncbi.nlm.nih.gov/pubmed/10634832

Publication citations

  1. Results

    Baumer JH, International randomised controlled trial of patient triggered ventilation in neonatal respiratory distress syndrome., Arch. Dis. Child. Fetal Neonatal Ed., 2000, 82, 1, F5-F10.

Additional files

Editorial Notes