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

Primary Purpose

Respiratory Distress Syndrome, Bronchopulmonary Dysplasia

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
NCPAP + standard air
NCPAP + Heliox
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring preterm infants, nasal continuous positive airway pressure, heliox, bronchopulmonary dysplasia.

Eligibility Criteria

28 Weeks - 32 Weeks (Child)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NCPAP + standard air

NCPAP + Heliox

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

surfactant need
number of doses of exogenous surfactant
major complications of prematurity
incidence of major complications of prematurity
ventilatory assistance
number of days of ventilatory assistance
length of stay
number of days of hospital stay

Full Information

First Posted
March 9, 2011
Last Updated
June 27, 2011
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT01383850
Brief Title
NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Keywords
preterm infants, nasal continuous positive airway pressure, heliox, bronchopulmonary dysplasia.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NCPAP + standard air
Arm Type
Active Comparator
Arm Title
NCPAP + Heliox
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
NCPAP + standard air
Intervention Description
NCAP (SiPAP, Vyasis) was used to administer standard air
Intervention Type
Other
Intervention Name(s)
NCPAP + Heliox
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy in reducing need of MV
Description
efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life
Time Frame
7 days
Secondary Outcome Measure Information:
Title
surfactant need
Description
number of doses of exogenous surfactant
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 10 weeks
Title
major complications of prematurity
Description
incidence of major complications of prematurity
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 10 weeks
Title
ventilatory assistance
Description
number of days of ventilatory assistance
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 10 weeks
Title
length of stay
Description
number of days of hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22291116
Citation
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.
Results Reference
derived

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

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