NIPAL: NIPPV vs.nCPAP During LISA Procedure

• Sponsor: University of Florence (Other)
• Overall Status: Completed
• CT.gov ID: NCT05796128
• Collaborator: (none)
• Enrollment: 202
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.7
• Patients Per Site Per Month: 7.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Newborn	Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV); Procedure: Nasal continuous positive airway pressure (NCPAP)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 202 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Oct 31, 2022
• Actual Study Completion Date: Jan 23, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Noninvasive ventilation [Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks]

   Duration of noninvasive ventilation

2. Mechanical ventilation [Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks]

   Duration ofmechanical ventilation

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Hours to 72 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Careggi University Hospital, Division of Neonatology	Florence		Italy	50141

Sponsors and Collaborators

• University of Florence

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carlo Dani, Full Professor of Pediatrics, University of Florence
• ClinicalTrials.gov Identifier: NCT05796128
• Other Study ID Numbers: NIPAL02
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carlo Dani, Full Professor of Pediatrics, University of Florence: Surfactant; LISA procedure; Preterm infant
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Apr 3, 2023