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

Study Overview
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Brief Summary
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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).

Conditions
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Respiratory Distress Syndrome, Bronchopulmonary Dysplasia

Intervention / Treatment
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* Other: NCPAP + standard air
* Other: NCPAP + Heliox


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NCPAP + standard air<br> | Other: NCPAP + standard air<br>* NCAP (SiPAP, Vyasis) was used to administer standard air<br>Other: NCPAP + Heliox<br>* 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.<br>|
| Experimental: NCPAP + Heliox<br> | Other: NCPAP + standard air<br>* NCAP (SiPAP, Vyasis) was used to administer standard air<br>Other: NCPAP + Heliox<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surfactant need | number of doses of exogenous surfactant | participants will be followed for the duration of hospital stay, an expected average of 10 weeks | 
| 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 | 
| ventilatory assistance | number of days of ventilatory assistance | participants will be followed for the duration of hospital stay, an expected average of 10 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants, nasal continuous positive airway pressure, heliox, bronchopulmonary dysplasia.