Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method

Study Overview
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Brief Summary
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Surfactant administration via thin catheter using a specially adapted video laryngoscope - a prospective, multicenter trial, assessing the feasibility of the VISUAL method (Video Surfactant Administration Laryngoscopy). The study will search for the number of attempts until surfactant is administrated, assessment of the infants' stability during the procedure, duration of the entire procedure, form laryngoscope insertion to surfactant administration.

Detailed Description
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In this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.). The laryngoscope is manufactured by Peak Medic Ltd, Natania, Israel. Primary Endpoints - Number of attempts until surfactant is administrated - Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia. - Duration of the entire procedure, form laryngoscope insertion to surfactants administration. 4. Secondary Endpoints - Need of invasive mechanical ventilation in the next 24 hours. - Complications reports - Subjective procedure scale of assessment - Unexpected pitfalls reports - Safety assessment of the procedure

Official Title
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Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - a Prospective, Multicenter Trial, Assessing the Feasibility of the VISUAL Method (Video Surfactant Administration Laryngoscopy)

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Device: VISUAL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Premature infants with gestational age 30-36 weeks. - Diagnosis of respiratory distress syndrome - Spontaneously breathing with non-invasive positive pressure ventilation. - Maximal age 3 days. Exclusion Criteria: - Apgar score at 5 min < 5 - Need for chest compressions or medication upon delivery. - Evident major congenital malformation, metabolic or genetic disorders. - Clinical evidence of sepsis.

Ages Eligible for Study
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Maximum Age: 3 Days

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
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment feasibility<br>feasibility, safety and effectiveness assessment | Device: VISUAL<br>* thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measures | Success for surfactant administration - yes / no | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures 1 | Assessment of the infants' SPO2 % | 1 year | 
| Secondary outcome measures 2 | Heart rate during the procedure | 1 year | 
| Secondary outcome measures 3 | Respiratory rate (breaths per minute) | 1 year | 
| Secondary outcome measures 4 | number of attempts for vocal cords visualization (number) | 1 year | 
| Secondary outcome measures 5 | Duration of the procedure (seconds) | 1 year | 
| Secondary outcome measures 6 | Need for mechanical ventilaton witin 24 hours following procedure (yes-no) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory distress syndrome, videolaryngoscopy, newborn infant, premature newborn infant, surfactant administration