Respiratory Distress Syndrome, Newborn
Conditions
Keywords
respiratory distress syndrome, videolaryngoscopy, newborn infant, premature newborn infant, surfactant administration
Brief summary
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
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 1. \- Number of attempts until surfactant is administrated 2. \- Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia. 3. \- Duration of the entire procedure, form laryngoscope insertion to surfactants administration. 4\. Secondary Endpoints 1. \- Need of invasive mechanical ventilation in the next 24 hours. 2. \- Complications reports 3. \- Subjective procedure scale of assessment 4. \- Unexpected pitfalls reports 5. \- Safety assessment of the procedure
Interventions
DEVICEVISUAL
thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy
Sponsors
Carmel Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Feasibility study
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No
Inclusion criteria
1. \- Premature infants with gestational age 30-36 weeks. 2. \- Diagnosis of respiratory distress syndrome 3. \- Spontaneously breathing with non-invasive positive pressure ventilation. 4. \- Maximal age 3 days.
Exclusion criteria
1. \- Apgar score at 5 min \< 5 2. \- Need for chest compressions or medication upon delivery. 3. \- Evident major congenital malformation, metabolic or genetic disorders. 4. \- Clinical evidence of sepsis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measures | 1 year | Success for surfactant administration - yes / no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome measures 2 | 1 year | Heart rate during the procedure |
| Secondary outcome measures 3 | 1 year | Respiratory rate (breaths per minute) |
| Secondary outcome measures 1 | 1 year | Assessment of the infants' SPO2 % |
| Secondary outcome measures 5 | 1 year | Duration of the procedure (seconds) |
| Secondary outcome measures 6 | 1 year | Need for mechanical ventilaton witin 24 hours following procedure (yes-no) |
| Secondary outcome measures 4 | 1 year | number of attempts for vocal cords visualization (number) |
Countries
Israel
Outcome results
None listed