NIPPV vs.nCPAP During LISA Procedure (NIPAL)

University of Florence (UNIFI)

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Procedure: Nasal continuous positive airway pressure (NCPAP); Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Study type: Interventional

Funder types: Other

Identifiers

NCT05796128

NIPAL02

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups

LISA with NCPAP

Active Comparator group

Description:

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

Treatment:

Procedure: Nasal continuous positive airway pressure (NCPAP)

LISA with NIPPV

Experimental group

Description:

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

Treatment:

Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)