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LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study

NCT04944108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-01-18

No results posted yet for this study

Summary

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE 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 total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction.

Conditions

  • Respiratory Distress Syndrome
  • Preterm Birth
  • Surfactant Deficiency Syndrome Neonatal

Interventions

PROCEDURE

LISA approach

Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) or the INSURE approach (tracheal tube)

PROCEDURE

Insure approach

Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2022-01-14
Completion
2022-01-14

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT04944108 on ClinicalTrials.gov