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

ISRCTN	ISRCTN62827057
DOI	https://doi.org/10.1186/ISRCTN62827057
Secondary identifying numbers	N0453192065

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 02/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Simon Mitchell
Scientific

SMH Central Manchester & Manchester Children's University Hospitals
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom

Email	simon.mitchell@cmmc.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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
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(s)	Tameside & Glossop REC, 21/12/2006, ref: 06/Q1402/72
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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	29/12/2006
Overall study end date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	150
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 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

England
United Kingdom

Study participating centre

SMH Central Manchester & Manchester Children's University Hospitals

Manchester
M13 0JH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

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

No information available

NHS R&D Support Funding

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

Editorial Notes

02/06/2017: No publications found, verifying study status with principal investigator