Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

Not Applicable

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: using specially adapted VNscope; Drug: surfactant administration

• Registration Number: NCT03846960
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Study Start: 2019-11-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. • Premature infants with gestational age 30-36 weeks.
2. • Diagnosis of respiratory distress syndrome
3. • Treatment with antenatal steroids.
4. • Spontaneously breathing with non-invasive positive pressure ventilation.
5. • 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
preterm infants	using specially adapted VNscope	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
preterm infants	surfactant administration	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

Primary Outcome Measures

Name	Time	Method
Number of attempts until surfactant is administrated	maximal age 3 days.	Number of intubation attempts- higher values represent a worse outcome
Duration of the entire procedure, form laryngoscope insertion to surfactants administration and Laryngoscope blade out of the mouth.	maximal age 3 days.	Time measurement of the procedure, sorter time indicate a better outcome
Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.	maximal age 3 days.	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

Secondary Outcome Measures

Name	Time	Method
Unexpected pitfalls reports	maximal age 3 days.	Physician assessment to evaluate eny pitfalls during the procedure
Need of invasive mechanical ventilation in the next 24 hours.	maximal age 3 days.	Failure of non-invasive approach and conversion to invasive ventilation to evaluate the efficiency of the procedure
Subjective procedure scale of assessment.	maximal age 3 days.	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
complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage	maximal age 3 days.	Documentation of the complication related to the procedure according to the clinical signs and chest x-ray after the procedure
Safety assessment of the procedure (Physician questionnaire)	maximal age 3 days.	Physician questionnaire- Do you feel VISUAL method is safe for the premature baby?; a)Yes b)Maybe c)No

Trial Locations

Locations (1)

Haemek medical centre; 🇮🇱 Afula, Israel