Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2020-10-01
2023-01-23
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LISA with NCPAP
In this group, infants will receive NCPAP during LISA procedure.
Nasal continuous positive airway pressure (NCPAP)
In this group, infants will receive NCPAP during LISA procedure.
LISA with NIPPV
In this group, infants will receive NIPPV during LISA procedure.
Nasal Intermittent Positive Pressure Ventilation (NIPPV)
In this group, infants will receive NIPPV during LISA procedure.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* -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
* -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.
0 Hours
72 Hours
ALL
No
Sponsors
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University of Florence
OTHER
Responsible Party
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Carlo Dani
Full Professor of Pediatrics
Locations
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Careggi University Hospital, Division of Neonatology
Florence, , Italy
Countries
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Other Identifiers
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NIPAL02
Identifier Type: -
Identifier Source: org_study_id
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