---
title: LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
nct_id: NCT04944108
overall_status: COMPLETED
phase: NA
sponsor: University Hospital Padova
study_type: INTERVENTIONAL
primary_condition: Respiratory Distress Syndrome
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04944108.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04944108"
ct_last_update_post_date: 2022-01-18
last_seen_at: "2026-05-12T06:48:02.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study

**Official Title:** Does LISA Change the Time of Device Positioning Compared to INSURE in Extremely Low Birth Weight Infants With RDS? A Crossover Randomized Controlled Manikin Trial

**NCT ID:** [NCT04944108](https://clinicaltrials.gov/study/NCT04944108)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** University Hospital Padova
- **Conditions:** Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- **Start Date:** 2021-12-16
- **Completion Date:** 2022-01-14
- **CT.gov Last Update:** 2022-01-18

## Brief 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.

## Detailed Description

Background: Although LISA offers some advantages in ventilation procedure and neonatal outcomes over INSURE, the use of a catheter during LISA may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device. This is likely to aggravate the invasiveness of the procedure, resulting in stressful consequences such as bradycardia, hypoxia and hemodynamic changes.

Objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.

Methods: 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.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

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

Exclusion Criteria:

* There are no exclusion criteria for this study.
```

## Arms

- **Surfactant administration with less invasive surfactant administration (LISA) approach** (EXPERIMENTAL) — Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter)
- **Surfactant administration with intubation (INSURE) approach** (ACTIVE_COMPARATOR) — Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)

## Interventions

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

## Primary Outcomes

- **Time of device positioning** _(time frame: 10 minutes)_ — Time needed for the correct positioning of the device into the trachea (thin catheter or tracheal tube). In case of failure, total time will be the sum of time of all attempts.

## Secondary Outcomes

- **Success of the procedure at the first attempt** _(time frame: 1 minute)_
- **Participant's satisfaction** _(time frame: 5 minutes)_
- **Number of attempts to insert the device in the trachea** _(time frame: 10 minutes)_
- **Correct depth of the device in the trachea** _(time frame: 10 minutes)_

## Locations (2)

- Poliambulanza Breacia, Brescia, Italy
- University Hospital of Padova, Padova, Italy

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.poliambulanza breacia|brescia||italy` — added _(2026-05-12)_
- `locations.university hospital of padova|padova||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04944108.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04944108*  
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