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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62827057
Enrollment
150
Registered
2007-09-28
Start date
2006-12-29
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases: Nasal trauma Neonatal Diseases Nasal trauma

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026