Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

Study Overview
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Brief Summary
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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 of Peak Medic Ltd, Netania, Israel.

Detailed Description
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A prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted VNscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube. Once neonates present respiratory distress, the adapted scope will be used - clinical and outcome measures will be collected to asses the safety and efficacy of the use

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

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: using specially adapted VNscope
* Drug: surfactant administration


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 - Treatment with antenatal steroids. - 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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Minimum Age: 30 Weeks
Maximum Age: 36 Weeks

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: intervention of a device product being evaluated in a small clinical trial to determine the feasibility of the product
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preterm infants<br>A prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted VNscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube. A feasibility study of 10 preterm infants 30-36 gestational age at birth, that requires surfactant administration for the indication of respiratory distress syndrome, and do not require immediate intubation | Device: using specially adapted VNscope<br>* surfactant administration via thin catheter using a specially adapted VNscope<br>* Other names: VNScope VNS0-000; VNBlade VNB0-000/1;Drug: surfactant administration<br>* surfactant administration via thin catheter using a specially adapted VNscope<br>* Other names: Curosurf - a porcine surfactant routinely used for RDS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts until surfactant is administrated | Number of intubation attempts- higher values represent a worse outcome | maximal age 3 days. | 
| Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia. | Monitoring the baby during the procedure and assessment of the infants' stability: hypoxia (Oxygen saturation less than 60% for more than 5 sec), bradycardia (HR less than 60 for more than 5 sec), tachycardia (HR more than 220 for more than 5 sec) bradycardia below 100 bpm and tachycardia above 220 bpm indicate worse outcome | maximal age 3 days. | 
| Duration of the entire procedure, form laryngoscope insertion to surfactants administration and Laryngoscope blade out of the mouth. | Time measurement of the procedure, sorter time indicate a better outcome | maximal age 3 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of invasive mechanical ventilation in the next 24 hours. | Failure of non-invasive approach and conversion to invasive ventilation to evaluate the efficiency of the procedure | maximal age 3 days. | 
| complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage | Documentation of the complication related to the procedure according to the clinical signs and chest x-ray after the procedure | maximal age 3 days. | 
| Subjective procedure scale of assessment. | Physician subjective assessment to evaluate the feasibility of the procedure- IRB- approved survey aims to assess user experiences with Video Surfactant Administration Laryngoscopy method in NICU. The survey contains five levels- a) Very satisfied b) Somewhat satisfied c) Neither satisfied nor dissatisfied d) Somewhat dissatisfied e) Very dissatisfied | maximal age 3 days. | 
| Unexpected pitfalls reports | Physician assessment to evaluate eny pitfalls during the procedure | maximal age 3 days. | 
| Safety assessment of the procedure (Physician questionnaire) | Physician questionnaire- Do you feel VISUAL method is safe for the premature baby? a)Yes b)Maybe c)No | maximal age 3 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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video laryngoscope, minimally invasive surfactant administration