Condition category
Respiratory
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
30/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sandra Calvert

ORCID ID

Contact details

Department of Child Health
St George's Hospital Medical School
Cranmer Terrace
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9700481

Study information

Scientific title

Acronym

Study hypothesis

1.To determine whether early intervention with high frequency oscillatory ventilation (HFOV) reduces the incidence of chronic lung disease (CLD), defined as a persistent oxygen requirement at a corrected gestational age of 36 weeks, in preterm infants born at less than 29 weeks gestation.
2.To ensure that any short term benefits of HFOV are not associated with an increase in subsequent respiratory or neurological morbidity

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

Chronic lung disease

Intervention

1. Early intervention with high frequency oscillatory ventilation (HFOV)
2. Control

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Composite variable:
1. Death before discharge from neonatal services
2. Chronic lung disease, defined as oxygen dependency 36 weeks post menstrual age (PMA)

Secondary outcome measures

1. Age at death
2. Age at final extubation
3. Failure of treatment
4. Abnormal cerebral ultrasound
5. Postnatal use of systematic steroids
6. Hearing loss greater than 60 dB
7. Pneumothorax
8. Age finally out of oxygen
9. Pulmonary haemorrhage
10. Patent ductus arteriosus
11. Retinopathy of prematurity
12. Age at discharge from hospital

Long-term outcome measures:
1. Respiratory morbidity over the first two years
2. Presence of disability at two years

Overall trial start date

26/01/1998

Overall trial end date

25/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Gestational age less than 29 weeks
2. Require endotracheal ventilation
3. It is considered appropriate that intensive care is continued
4. No identified major congenital malformation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

800

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

26/01/1998

Recruitment end date

25/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Child Health
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/12200550
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24972254

Publication citations

  1. Results

    Johnson AH, Peacock JL, Greenough A, Marlow N, Limb ES, Marston L, Calvert SA, , High-frequency oscillatory ventilation for the prevention of chronic lung disease of prematurity., N. Engl. J. Med., 2002, 347, 9, 633-642, doi: 10.1056/NEJMoa020432.

  2. Results

    Greenough A, Peacock J, Zivanovic S, Alcazar-Paris M, Lo J, Marlow N, Calvert S, United Kingdom Oscillation Study: long-term outcomes of a randomised trial of two modes of neonatal ventilation., Health Technol Assess, 2014, 18, 41, v-xx, 1-95, doi: 10.3310/hta18410.

Additional files

Editorial Notes