NIPPV vs.nCPAP During LISA Procedure (NIPAL)

March 21, 2023 updated by: Carlo Dani, University of Florence

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50141
        • Careggi University Hospital, Division of Neonatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LISA with NCPAP
In this group, infants will receive NCPAP during LISA procedure.
Procedure: Nasal continuous positive airway pressure (NCPAP)
In this group, infants will receive NCPAP during LISA procedure.
Experimental: LISA with NIPPV
In this group, infants will receive NIPPV during LISA procedure.
Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)
In this group, infants will receive NIPPV during LISA procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Need for a second dose of surfactant or mechanical ventilation
The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Noninvasive ventilation
Time Frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Duration of noninvasive ventilation
Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Mechanical ventilation
Time Frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Duration ofmechanical ventilation
Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Bronchopulmonary dysplasia
Time Frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Frequency of mild, moderate, and severe bronchopulmonary dysplasia
Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

January 23, 2023

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPAL02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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