Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method

NCT04406142 | Completed DMC

• 1 other identifier: CMC-17-0007-CTIL
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

respiratory distress syndrome; videolaryngoscopy; newborn infant; premature newborn infant; surfactant administration

Outcome Measures

Primary Outcomes (1)

• Primary outcome measures

  Success for surfactant administration - yes / no

  1 year

Secondary Outcomes (6)

• Secondary outcome measures 1

  1 year

• Secondary outcome measures 2

  1 year

• Secondary outcome measures 3

  1 year

• Secondary outcome measures 4

  1 year

• Secondary outcome measures 5

  1 year

Study Arms (1)

treatment feasibility

EXPERIMENTAL

feasibility, safety and effectiveness assessment

Device: VISUAL

Interventions

VISUAL DEVICE

thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

treatment feasibility

Eligibility Criteria

• Age: Up to 3 Days
• 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
• \- 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

• Carmel Medical Center: lead

Study Sites (1)

Department of Neonatology, Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dan I Waisman, MD

  Department of Neonatology, Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Newborn Unit Department of Neonatology

Model Details: Feasibility study

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: May 28, 2020
• Study Start: July 15, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

IL (1)