Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope (VISUAL)

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Respiratory Distress Syndrome

Treatments: Device: using specially adapted VNscope; Drug: surfactant administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03846960

0149-18-EMC

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 36 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

preterm infants

Experimental group

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. 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

Treatment:

Drug: surfactant administration

Device: using specially adapted VNscope