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NIPPV vs.nCPAP During LISA Procedure (NIPAL)

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Nasal continuous positive airway pressure (NCPAP)

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring Surfactant, LISA procedure, Preterm infant

Eligibility Criteria

0 Hours - 72 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: -Infants with gestational age between 25+0 and 31+6 gestational weeks, -RDS which does not require MV -Treatment with NCPAP and FiO2 >0.30 within the first 6 hours of life, -First dose of caffeine administered Exclusion Criteria: -absence of informed consent, -major congenital malformations, -hydrops fetalis, -chromosomal diseases, -previous treatment with surfactant, -cardiorespiratory instability requiring treatment with vasoactive drugs, -pneumothorax, -death within 72 hours of life.

Sites / Locations

Careggi University Hospital, Division of Neonatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LISA with NCPAP

LISA with NIPPV

Arm Description

In this group, infants will receive NCPAP during LISA procedure.

In this group, infants will receive NIPPV during LISA procedure.

Outcomes

Primary Outcome Measures

Surfactant or mechanical ventilation

Need for a second dose of surfactant or mechanical ventilation

Secondary Outcome Measures

Noninvasive ventilation

Duration of noninvasive ventilation

Mechanical ventilation

Duration ofmechanical ventilation

Bronchopulmonary dysplasia

Frequency of mild, moderate, and severe bronchopulmonary dysplasia

Full Information

NCT ID

NCT05796128

First Posted

March 8, 2023

Last Updated

March 21, 2023

Sponsor

University of Florence

1. Study Identification

Unique Protocol Identification Number

NCT05796128

Brief Title

NIPPV vs.nCPAP During LISA Procedure

Acronym

NIPAL

Official Title

Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

October 31, 2022 (Actual)

Study Completion Date

January 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Florence

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants. The main question it aims to answer is: • Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 >0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome, Newborn

Keywords

Surfactant, LISA procedure, Preterm infant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LISA with NCPAP

Arm Type

Active Comparator

Arm Description

In this group, infants will receive NCPAP during LISA procedure.

Arm Title

LISA with NIPPV

Arm Type

Experimental

Arm Description

In this group, infants will receive NIPPV during LISA procedure.

Intervention Type

Procedure

Intervention Name(s)

Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Intervention Description

In this group, infants will receive NIPPV during LISA procedure.

Intervention Type

Procedure

Intervention Name(s)

Nasal continuous positive airway pressure (NCPAP)

Intervention Description

In this group, infants will receive NCPAP during LISA procedure.

Primary Outcome Measure Information:

Title

Surfactant or mechanical ventilation

Description

Need for a second dose of surfactant or mechanical ventilation

Time Frame

The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life

Secondary Outcome Measure Information:

Title

Noninvasive ventilation

Description

Duration of noninvasive ventilation

Time Frame

Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

Title

Mechanical ventilation

Description

Duration ofmechanical ventilation

Time Frame

Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

Title

Bronchopulmonary dysplasia

Description

Frequency of mild, moderate, and severe bronchopulmonary dysplasia

Time Frame

Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Hours

Maximum Age & Unit of Time

72 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Careggi University Hospital, Division of Neonatology

City

Florence

ZIP/Postal Code

50141

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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NIPPV vs.nCPAP During LISA Procedure

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