Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome

Study Overview
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Brief Summary
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is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

Detailed Description
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Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30. Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30. Non-invasive respiratory support failure is set as follows: FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher, Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation, Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis, Severe respiratory distress, Pulmonary haemorrhage and cardiopulmonary arrest.

Official Title
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Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks

Conditions
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Ventilatory Failure

Intervention / Treatment
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* Device: ventilator NCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included Exclusion Criteria: Major congenital anomalies Presence of cardiovascular instability Intubation at admission to the NICU Consent not provided or refused

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 2 Hours

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: Ventilator NCPAP<br>neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O | Device: ventilator NCPAP<br>* infants will be randomized into two different NCPAP groups<br>* Other names: infant flow driver NCPAP;|
| Active Comparator: Infant Flow-driver NCPAP<br>infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow | Device: ventilator NCPAP<br>* infants will be randomized into two different NCPAP groups<br>* Other names: infant flow driver NCPAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| noninvasive ventilation failure | need for mechanical ventilation in the first 72 hours of life | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NCPAP, Respiratory Distress Syndrome