Condition category
Neonatal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
03/02/2015
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 Simon Mitchell

ORCID ID

Contact details

SMH Central Manchester & Manchester Children's University Hospitals
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom
-
simon.mitchell@cmmc.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0453192065

Study information

Scientific title

Randomised trial of nasal prongs versus nasal mask for the avoidance of nasal trauma with prolonged nasal continuous positive airway pressure (NCPAP) using the infant flow driver in infants <27 weeks gestation

Acronym

Study hypothesis

To compare the frequency of nasal trauma during nasal CPAP delivered with an infant Flow Driver using two different methods (nasal prongs or nasal mask), both of which are in regular use on the neonatal medical unit.

Ethics approval

Tameside & Glossop REC, 21/12/2006, ref: 06/Q1402/72

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neonatal Diseases: Nasal trauma

Intervention

The study aims to examine the use of NCPAP in infants requiring support for evolving / established lung disease. It is not intended to study infants in the acute phase of their respiratory illness or within 24 hours of extubation. Following informed parental consent, infants below 27 weeks gestation will be randomised to one or three groups once they reach 48 hours of age or require continuing NCPAP more than 24 hours post extubation (whichever occurs later).

Infants will be randomised into three groups:
Group 1: (control) Nasal Prongs
Group 2: Nasal Mask
Group 3: Nasal prongs alternating with nasal mask at 8 hourly intervals

Randomisation will be by sealed numbered envelopes prepared using block randomisation by personnel not involved in the study.

The infant's nasal septum and philtrum will be assessed prior to commencing NCPAP to exclude the possibility of pre-existing skin trauma. Whilst receiving NCPAP, the condition of the infants nose will be assessed with each routine set of nursing cares, consistent with existing normal practice. For the purposes of this study, a dedicated form will be used to record these findings. Infants who are subsequently re-ventilated due to undercurrent problems or worsening lung disease will receive NCPAP via nasal prongs for the first 24 hours post extubation before reverting to their randomisation group thereafter. If there are any concerns regarding the development of nasal trauma, infants may be changed to an alternative mode of delivery (e.g. from nasal prongs to mask) or managed off CPAP, as decided by the clinical staff caring for the infant according to the infant's clinical condition and the decision and its reason recorded. Because of the nature of the intervention, blinding is not possible in this study.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Frequency of the superficial skin injury (defined as discolourisation or abrasion of the skin) in each group, analysed in an intention to treat basis.

Secondary outcome measures

Proportion of infants from each group who do not continue with their allocated treatment group due to practical difficulties with the device.

Overall trial start date

29/12/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants <27 weeks gestation admitted to SMH
2. Requiring NCPAP beyond 48 hours from birth or more than 24 hours post extubation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

150

Participant exclusion criteria

Added June 2008:
1. Major congenital abnormality
2. Facial or airway abnormality precluding the use of NCPAP

Recruitment start date

29/12/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

SMH Central Manchester & Manchester Children's University Hospitals
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

Hospital/treatment centre

Funder name

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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