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

Bronchopulmonary Dysplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383850
• Other study ID #: Heliox
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2011
• Last updated: June 27, 2011
• Start date: February 2008
• Est. completion date: September 2010

Study information

• Verified date: June 2011
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 32 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• NCPAP + standard air
NCAP (SiPAP, Vyasis) was used to administer standard air
• NCPAP + Heliox
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.

Locations

Country	Name	City	State
Italy	NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days	No
Secondary	surfactant need	number of doses of exogenous surfactant	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	No
Secondary	major complications of prematurity	incidence of major complications of prematurity	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	No
Secondary	ventilatory assistance	number of days of ventilatory assistance	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	No
Secondary	length of stay	number of days of hospital stay	participants will be followed for the duration of hospital stay, an expected average of 10 weeks	No