LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS

NCT05399628 | Completed

• 1 other identifier: NEOUNIPD2(2022)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Conditions

Respiratory Distress Syndrome, Newborn

Outcome Measures

Primary Outcomes (1)

• Number of participants who will achieve the positioning of the device at the correct depth in the trachea

  Number of participants who will achieve the positioning of the device at the correct depth in the trachea (as assessed by the external observer using a laryngoscope).

  5 minutes

Secondary Outcomes (3)

• Time for positioning the device in the trachea

  5 minutes

• Number of attempts for positioning the device in the trachea

  5 minutes

• Participant opinion on using the device

  10 minutes

Study Arms (2)

Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter

EXPERIMENTAL

Participants will be assigned to perform the procedure with a LISA catheter with a marked tip

Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter

Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter

ACTIVE COMPARATOR

Participants will be assigned to perform the procedure with a LISA catheter with an unmarked tip

Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter

Interventions

Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter DEVICE

Participants will be assigned to perform the procedure with LISA catheter with a marked tip

Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter

Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter DEVICE

Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip

Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Level III NICU consultants and residents will be eligible to participate in the study

You may not qualify if:

• Refusal to participate in the study.

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

Daniele Trevisanuto

Padua, 35128, Italy

Location

Related Publications (1)

• Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.

  PMID: 30974433 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the characteristics of the intervention, both participants and outcome assessors cannot be masked. The statistician will be blind to the intervention arms.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants in AB arm will be assigned to perform the procedure with LISA catheter with marked tip, followed by the procedure with LISA catheter with unmarked tip. Participants in BA arm will be assigned to the reverse sequence. A washout period of 6 hours (one procedure in the morning and one in the afternoon) will be included to reduce any carryover effect

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: June 6, 2022
• Primary Completion: June 11, 2022
• Study Completion: June 11, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

IT (1)