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Completed

NCT Number: NCT01383850

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

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).

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Key information

Conditions

Respiratory Distress Syndrome Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiration Disorders Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Milan, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NCPAP + standard air

Other

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

NCPAP + Heliox

Other

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 outcomes

  1. Efficacy in reducing need of MV

    Time frame: 7 days

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

Secondary outcomes

  1. surfactant need

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

    number of doses of exogenous surfactant

  2. major complications of prematurity

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

    incidence of major complications of prematurity

  3. ventilatory assistance

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

    number of days of ventilatory assistance

  4. length of stay

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

    number of days of hospital stay

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 28, 2011
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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