Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

NCT03846960 | Unknown

• 1 other identifier: 0149-18-EMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome

Keywords

video laryngoscope; minimally invasive surfactant administration

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Need of invasive mechanical ventilation in the next 24 hours.

  maximal age 3 days.

• complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage

  maximal age 3 days.

• Subjective procedure scale of assessment.

  maximal age 3 days.

• Unexpected pitfalls reports

  maximal age 3 days.

• Safety assessment of the procedure (Physician questionnaire)

  maximal age 3 days.

Study Arms (1)

preterm infants

EXPERIMENTAL

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; Drug: surfactant administration

Interventions

using specially adapted VNscope DEVICE

surfactant administration via thin catheter using a specially adapted VNscope

Also known as: VNScope VNS0-000; VNBlade VNB0-000/1

preterm infants

surfactant administration DRUG

surfactant administration via thin catheter using a specially adapted VNscope

Also known as: Curosurf - a porcine surfactant routinely used for RDS

preterm infants

Eligibility Criteria

• Age: 30 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Carmel Medical Center: collaborator

Study Sites (1)

Haemek medical centre

Afula, Israel

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Thiosulfate Sulfurtransferase

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Sulfurtransferases; Sulfur Group Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Gil talmon, dr

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Neonatologist

Model Details: intervention of a device product being evaluated in a small clinical trial to determine the feasibility of the product

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: February 20, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

IL (1)