NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase

Completed

Phase 2

Conditions

Respiratory Distress Syndrome

Bronchopulmonary Dysplasia

Treatments

Other: NCPAP + standard air

Other: NCPAP + Heliox

Study type

Interventional

Funder types

Other

Identifiers

NCT01383850

Heliox

Details and patient eligibility

About

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).

Enrollment

51 patients

Sex

All

Ages

28 to 32 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

inborn infants between 28 and 32 weeks of GA
Silverman score > 5,
radiological finding of RDS
a requirement of inspiratory flow of oxygen (FiO2) > 0,25 (SaO2 ) between 88-95% within the first hour of life.

Exclusion criteria

major congenital malformations
intraventricular hemorrhage (IVH) more than grade 2
need of intubation in the delivery room or requirement of FiO2 >0,4 during the first hour of life.