NIPPV vs.nCPAP During LISA Procedure

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Newborn
• Interventions: Procedure: Nasal continuous positive airway pressure (NCPAP); Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)

• Registration Number: NCT05796128
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-10-31
• Study Completion: 2023-01-23
• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LISA with NCPAP	Nasal continuous positive airway pressure (NCPAP)	In this group, infants will receive NCPAP during LISA procedure.
LISA with NIPPV	Nasal Intermittent Positive Pressure Ventilation (NIPPV)	In this group, infants will receive NIPPV during LISA procedure.

Primary Outcome Measures

Name	Time	Method
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	Need for a second dose of surfactant or mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation	Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks	Duration ofmechanical ventilation
Noninvasive ventilation	Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks	Duration of noninvasive ventilation
Bronchopulmonary dysplasia	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

Trial Locations

Locations (1)

Careggi University Hospital, Division of Neonatology; 🇮🇹 Florence, Italy