Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2000 results in: http://www.ncbi.nlm.nih.gov/pubmed/10634832
Publication citations
-
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.