NCT01383850

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

2.6 years

First QC Date

March 9, 2011

Last Update Submit

June 27, 2011

Conditions

Respiratory Distress SyndromeBronchopulmonary Dysplasia

Keywords

preterm infantsnasal continuous positive airway pressurehelioxbronchopulmonary dysplasia.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • surfactant need

    participants will be followed for the duration of hospital stay, an expected average of 10 weeks

  • major complications of prematurity

    participants will be followed for the duration of hospital stay, an expected average of 10 weeks

  • ventilatory assistance

    participants will be followed for the duration of hospital stay, an expected average of 10 weeks

  • length of stay

    participants will be followed for the duration of hospital stay, an expected average of 10 weeks

Study Arms (2)

NCPAP + standard air

ACTIVE COMPARATOR
Other: NCPAP + standard airOther: NCPAP + Heliox

NCPAP + Heliox

EXPERIMENTAL
Other: NCPAP + standard airOther: NCPAP + Heliox

Interventions

NCPAP + standard airOTHER

NCAP (SiPAP, Vyasis) was used to administer standard air

NCPAP + HelioxNCPAP + standard air
NCPAP + HelioxOTHER

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.

NCPAP + HelioxNCPAP + standard air

Eligibility Criteria

Age28 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano

Milan, 20122, Italy

Location

Related Publications (1)

  • Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.

    PMID: 22291116DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeBronchopulmonary Dysplasia

Interventions

heliox

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersVentilator-Induced Lung InjuryLung InjuryInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2011

First Posted

June 28, 2011

Study Start

February 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

IT(1)