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

Phase 2

Completed

• Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia
• Interventions: Other: NCPAP + standard air; Other: NCPAP + Heliox

• Registration Number: NCT01383850
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2011-03-09
• Status Verified: 2011-06
• Study First Submitted QC: 2011-06-27
• Last Update Submitted: 2011-06-27
• Study First Posted: 2011-06-28
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCPAP + standard air	NCPAP + standard air	-
NCPAP + standard air	NCPAP + Heliox	-
NCPAP + Heliox	NCPAP + standard air	-
NCPAP + Heliox	NCPAP + Heliox	-

Primary Outcome Measures

Name	Time	Method
Efficacy in reducing need of MV	7 days	efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life

Secondary Outcome Measures

Name	Time	Method
surfactant need	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	number of doses of exogenous surfactant
major complications of prematurity	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	incidence of major complications of prematurity
ventilatory assistance	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	number of days of ventilatory assistance
length of stay	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	number of days of hospital stay

Trial Locations

Locations (1)

NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano; 🇮🇹 Milan, Italy