Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

Study Overview
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Brief Summary
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This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive LISA + SNIPPV technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.

Official Title
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Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

Conditions
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Respiratory Distress Syndrome of Newborn

Intervention / Treatment
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* Procedure: LISA+SNIPPV
* Procedure: traditional InSurE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premature infants with birth weight < 2500g and gestational age < 36+6 weeks; High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS. the participating hospital obtained the consent of the Ethics Committee. parental informed consents were obtained. Exclusion Criteria: severe congenital malformations. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics. congenital hereditary metabolic diseases. parental informed consent was not obtained.

Ages Eligible for Study
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Maximum Age: 1 Year

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LISA+SNIPPV group<br>receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation | Procedure: LISA+SNIPPV<br>* The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.<br>|
| Active Comparator: InSurE group<br>receives intubation-surfactant- extubation technique and selects CPAP ventilation | Procedure: traditional InSurE<br>* The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the average duration of mechanical ventilation | the average duration of mechanical ventilation of each group | 40 weeks | 
| the duration of oxygen therapy | the duration of oxygen therapy of each group | 40 weeks | 
| the incidence of BPD | the incidence of BPD in each group | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Severity Score (PSC) | PSC was defined as FiO2 × support + medications, where FiO2 is the actual or 'effective' (for nasal cannula) FiO2; support is 2.5 for a ventilator, 1.5 for nasal continuous positive airway pressure, or 1.0 for nasal cannula or hood oxygen; and medications is 0.20 for systemic steroids for BPD, 0.10 each for regular diuretics or inhaled steroids, and 0.05 each for methylxanthines or intermittent diuretics. The scores can range from 0.21 to 2.95. | 1st, 2nd, 3rd, 7th, 14th, 28th days | 
| the incidence of complications | the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation) | 40 weeks | 
| oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) | oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) | the period of oxygen therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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InSurE, LISA, SNIPPV