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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.
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
4. Secondary Endpoints
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment feasibility | Experimental | feasibility, safety and effectiveness assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VISUAL | Device | thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome measures | Success for surfactant administration - yes / no | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measures 1 | Assessment of the infants' SPO2 % | 1 year |
| Secondary outcome measures 2 | Heart rate during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan I Waisman, MD | Department of Neonatology, Carmel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology, Carmel Medical Center | Haifa | Israel |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
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Feasibility study
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| 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 |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |