CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Less Invasive Surfactant Administration LISA +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04209946
NCT04209946N/ACompleted
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A Multicenter, Randomized Trial of Preterm Infants Receiving Caffeine and Less Invasive Surfactant Administration Compared to Caffeine and Early Continuous Positive Airway Pressure (CaLI Trial)

Sharp HealthCare·interventional·Posted Dec 24, 2019·Updated Dec 18, 2025

In Brief

A clinical study evaluating Less Invasive Surfactant Administration LISA and Continuous Positive Airway Pressure CPAP for Premature Lungs and 2 related conditions. Completed, enrolled 180 participants across 3 sites.

Detailed Summary

This study is being conducted to determine whether prophylactic administration of surfactant by the Less Invasive Surfactant Administration (LISA) method reduces the need for mechanical ventilation in the first 72 hours of life when compared to early Continuous Positive Airway Pressure (CPAP) alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Lungs, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal
CountriesUnited States
CollaboratorsSharp Mary Birch Hospital for Women & Newborns, Loma Linda University, University of California, Irvine

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 24, 2019
Enrollment StartJan 22, 2020
Primary CompletionMay 8, 2023
Study CompletionNov 10, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.5 years ago

Interventions

Less Invasive Surfactant Administration LISAprocedure

Laryngoscopy with insertion of a small 16 gauge angiocatheter to administer FDA approved Surfactant, during spontaneous respirations.

Continuous Positive Airway Pressure CPAPprocedure

Infant will remain on CPAP Therapy during spontaneous respirations