CompletedNot Applicable

HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP for Respiratory Distress Syndrome of Prematurity

Italy316 participantsStarted 2012-01

Plain-language summary

Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2) HHHFNC providing a flow 4-6 l/min. The aim of the study is to assess efficacy and safety of relative "new" form of respiratory support (HHHFNC) versus a more common one (NCPAP).

Who can participate

Age range29 Weeks – 36 Weeks

SexALL

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Inclusion Criteria: * Inborn * Parental Consent Exclusion Criteria: * No parental consent * Major congenital malformations * Severe intra ventricular hemorrage diagnosed early after birth

What they're measuring

number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode

Timeframe: within 72 hrs from the beginning of the study mode

Trial details

NCT IDNCT02570217

SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Newborn Respiratory Distress Syndrome trials