Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Study Overview
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Brief Summary
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With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.

Official Title
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Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Procedure: Use tracheal intubation for surfactant therapy
* Procedure: Use of Proseal laryngeal mask airway for surfactant therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birthweight more than 1000 grams Gestational age more than 28 weeks and less than 35 weeks Chronologic age less than 8 hours Diagnosis of RDS by clinical and radiographic criteria Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30% Parental consent Exclusion Criteria: Birthweight less than 1000 grams Gestational age more than 28 weeks and less than 35 weeks Chronologic age more than 8 hours Maternal fever or premature rupture of fetal membranes less than 18 hours Diagnosis other than respiratory distress syndrome Babies who require or have already had endotracheal intubation Analgesia and or sedation during the first six hours of life Apgar 5 minute score less than three Babies with congenital anomalies or signs of acute circulatory failure

Ages Eligible for Study
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Minimum Age: 30 Minutes
Maximum Age: 8 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: Tracheal intubation<br>Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency. | Procedure: Use tracheal intubation for surfactant therapy<br>* Surfactant endotracheal administration after tracheal intubation<br>* Other names: Endotracheal tube;|
| Experimental: Proseal laryngeal mask airway<br>Laryngeal mask airway is a airway device used for ventilation with self-inflating bag or flow-inflating bag. In this study it will be used for surfactant administration, in preterm babies with SDR surfactant deficiency. | Procedure: Use of Proseal laryngeal mask airway for surfactant therapy<br>* Surfactant use by proseal laryngeal mask airway<br>* Other names: Laryngeal mask airway;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of inspired oxygen |  | three hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal evaluation of pain |  | three hours | 
| Proseal laryngeal mask surfactant treatment failure |  | Six hours | 
| Rate of respiratory distress syndrome complications |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal intubation, proseal laryngeal mask airway, neonate, surfactant, respiratory distress syndrome