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
Contact information
Dr Harry Baumer
Scientific
Scientific
Plymouth Hospitals NHS Trust
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
| Phone | +44 (0)1752 763450 |
|---|---|
| harry.baumer@phnt.swest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal diseases |
| Intervention | 1. Trigger ventilation 2. Conventional ventilation |
| Intervention type | Other |
| 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 study start date | 01/11/1994 |
| Completion date | 31/03/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 924 |
| Key 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 |
| Key exclusion criteria | Babies with evidence of major congenital malformation or evidence of inhalational pneumonitis will be excluded |
| Date of first enrolment | 01/11/1994 |
| Date of final enrolment | 31/03/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Plymouth Hospitals NHS Trust
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
