Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
15/04/2009
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 Samir Gupta

ORCID ID

Contact details

South Tees Hospital Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227165400

Study information

Scientific title

Acronym

Study hypothesis

To compare the efficacy and safety of two different systems of delivering nasal continuous positive airway pressure for successful extubation of preterm infants.

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

Treatment

Patient information sheet

Condition

Neonatal Diseases: Respiratory

Intervention

Babies up to 30 week gestation and requiring ventilatory support would be eligible for study pre-extubation. Signed informed parental consent will be sought before randomisation.Babies will be randomised onto one of the currently used CPAP modes: Infant Flow Driver or Bubble CPAP.
Nursing care including monitoring will be as per unit protocols. The successful extubation (primary outcome) will be analysed as per pre-defined clinical and physiological criteria. Each group will be analysed based on duration of ventilation (less than and equal to 2 weeks, and more than 2 weeks). Total number of babies required will be 59 each group.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Respiratory failure within 72 hours defined as:
1. Need for re-intubation primarily for respiratory distress AND/OR
2. Uncompensated Respiratory Acidosis (pH<7.2 AND pCO2>8kPa

Secondary outcome measures

1. Endotracheal reintubation
2. Duration of CPAP days
3. Chronic Lung Disease, Morbidity, Mortality and Data on complications including gastrointestinal will be collected.

Overall trial start date

01/10/2004

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Born between 24 and less than 30 weeks gestation, or with a birth weight of 600 to 1500 grams
2. Endotracheal intubation for any duration
3. Stable or improving respiratory status with inspired oxygen concentration of less than 50%
4. First extubation attempt
5. Signed parental consent
6. Considered ready for extubation by the clinical management team

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Total number of babies required will be 59 each group

Participant exclusion criteria

1. Major congenital malformations, which are known to adversely affect life expectancy
2. Known congenital or acquired upper airway obstruction
3. Neuromuscular disorders

Recruitment start date

01/10/2004

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Tees Hospital Trust
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Tees Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19230906

Publication citations

  1. Results

    Gupta S, Sinha SK, Tin W, Donn SM, A randomized controlled trial of post-extubation bubble continuous positive airway pressure versus Infant Flow Driver continuous positive airway pressure in preterm infants with respiratory distress syndrome., J. Pediatr., 2009, 154, 5, 645-650, doi: 10.1016/j.jpeds.2008.12.034.

Additional files

Editorial Notes