Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
NCAP (SiPAP, Vyasis) was used to administer standard air
Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.
NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano
Milan, Italy
Efficacy in reducing need of MV
efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life
Time frame: 7 days
surfactant need
number of doses of exogenous surfactant
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
major complications of prematurity
incidence of major complications of prematurity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
ventilatory assistance
number of days of ventilatory assistance
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
length of stay
number of days of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
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