NIPPV vs.nCPAP During LISA Procedure

Respiratory Distress Syndrome, Newborn Clinical Trial

— NIPAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05796128
• Other study ID #: NIPAL02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 23, 2023

Study information

• Verified date: March 2023
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: January 23, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 72 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Nasal Intermittent Positive Pressure Ventilation (NIPPV)
In this group, infants will receive NIPPV during LISA procedure.
• Nasal continuous positive airway pressure (NCPAP)
In this group, infants will receive NCPAP during LISA procedure.

Locations

Country	Name	City	State
Italy	Careggi University Hospital, Division of Neonatology	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surfactant or mechanical ventilation	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	Noninvasive ventilation	Duration of noninvasive ventilation	Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Secondary	Mechanical ventilation	Duration ofmechanical ventilation	Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Secondary	Bronchopulmonary dysplasia	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