Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants

Study Overview
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Brief Summary
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The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.

Conditions
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Noninvasive Ventilation for Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Nasal CPAP (SLE)
* Device: Nasal IMV (SLE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Gestational age 26-32 weeks The criteria for failure were met by at least 1 of the following: pH: 7.10 and PaCO2: 70 mm Hg Recurrent apnea with >3 episodes (Prophylactic caffeine were used in all infants) Single episode of apnea that required bag-and-mask ventilation PaO2: 50 mmHg with a fraction of inspired oxygen of >0.5. 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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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: Nasal Continuous Positive Airway Pressure (CPAP)<br>After 2 hours evaluation: Infants needed invasive MV (mechanic ventilation) or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%. Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose | Device: Nasal CPAP (SLE)<br>* PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute<br>* Other names: SLE 2000, SLE 5000;|
| Active Comparator: Nasal Intermittent Mandatory Ventilation (IMV)<br>After 2 hours evaluation: Infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of > 88% to 92%. Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose | Device: Nasal IMV (SLE)<br>* PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute<br>* Other names: SLE 2000, SLE 5000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants | If infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of respiratory support | respiratory insufficiency, pneumothorax | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal CPAP, Nasal IMV, Surfactant, Preterm infants