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

NCT05399628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-26

No results posted yet for this study

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

Interventions

DEVICE

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

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

DEVICE

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

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

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2022-06-11
Completion
2022-06-11

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05399628 on ClinicalTrials.gov