Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/08/2012
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

Prof Richard Cooke

ORCID ID

Contact details

Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 708 9988

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0128138699

Study information

Scientific title

Acronym

Study hypothesis

Early intubation and surfactant therapy followed by extubation to NCPAP in preterm infants of less than 29 weeks gestation with RDS when compared to continued intubation and intermittent positive pressure ventilation (IPPV) will result in a 50% reduction in chronic lung disease (CLD) (O2 dependency at 36 weeks post menstrual age).

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Neonatal Diseases: Respiratory

Intervention

Early intubation and surfactant therapy followed by extubation to NCPAP compared with continued intubation and intermittent positive pressure ventilation (IPPV)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Proportion of infants receiving added oxygen and/or respiratory support at 36 weeks post menstrual age.

Secondary outcome measures

1. Days of respiratory support
2. Days of added oxygen
3. Death
4. Pneumothorax rate
5. Sepsis rate (positive blood culture)
6. Trauma rates (nasal septal injury, tracheal stenosis)
7. Change in weight and head circumference centiles between birth and discharge (Z scores).

Overall trial start date

07/10/2003

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

200 infants

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

200 infants

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

07/10/2003

Recruitment end date

01/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Liverpool Women's Hospital NHS Trust (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

Publication citations

Additional files

Editorial Notes