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 |
| Protocol serial number | N0453192065 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Central Manchester and Manchester Children's University Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Simon Mitchell
Scientific
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Frequency of the superficial skin injury (defined as discolourisation or abrasion of the skin) in each group, analysed in an intention to treat basis. |
| Key secondary outcome measure(s) |
Proportion of infants from each group who do not continue with their allocated treatment group due to practical difficulties with the device. |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key exclusion criteria | Added June 2008: 1. Major congenital abnormality 2. Facial or airway abnormality precluding the use of NCPAP |
| Date of first enrolment | 29/12/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SMH Central Manchester & Manchester Children's University Hospitals
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/06/2017: No publications found, verifying study status with principal investigator
