CompletedNot Applicable

Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment

Sweden50 participantsStarted 2018-08-01

Plain-language summary

The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age. For infants with an interface leakage, the trial also includes an observational part evaluating simple measures to reduce leakage. The study will be carried out in the Karolinska University Hospital Stockholm and in the Östersund Hospital.

Who can participate

Age range44 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gestational age over 28 weeks (corrected age) at the time of inclusion * Patient receiving respiratory support with CPAP Exclusion Criteria: * Airway, pulmonary, cardiac or gastro-intestinal malformations * Neuromuscular disease * Circulatory unstable patient * FiO2 higher than 0.5 * Nasal damage or major skin irritation. * Extubation less than 24 h before investigation * Surgery less than 5 days before investigation

What they're measuring

Leakage in the CPAP system

Timeframe: 0-60 min

Trial details

NCT IDNCT03586856

SponsorBaldvin Jonsson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-26

View on ClinicalTrials.gov More Respiration; Insufficient or Poor, Newborn trials