Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-12-31

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.

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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

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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preterm infants

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

Group Type EXPERIMENTAL

using specially adapted VNscope

Intervention Type DEVICE

surfactant administration via thin catheter using a specially adapted VNscope

surfactant administration

Intervention Type DRUG

surfactant administration via thin catheter using a specially adapted VNscope

Interventions

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using specially adapted VNscope

surfactant administration via thin catheter using a specially adapted VNscope

Intervention Type DEVICE

surfactant administration

surfactant administration via thin catheter using a specially adapted VNscope

Intervention Type DRUG

Other Intervention Names

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VNScope VNS0-000; VNBlade VNB0-000/1 Curosurf - a porcine surfactant routinely used for RDS

Eligibility Criteria

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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.

Minimum Eligible Age

30 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No