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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants

Study acronym: SALTI
StatusRecruiting
PhaseNot applicable
Started2026-08-05
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 day later across 2 updates Jun 2028 → Jul 2028
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from University of Texas Southwestern Medical Center

Amendment history

2026-08-24
Study Status, Study Description, Outcome Measures, Eligibility v6
Primary endpoint(s) modified1 entry, revised
WasNumber of events of bradycardia and hypoxemia during surfactant administration
NowCombined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration
Primary completion moved earlier: 2028-09 → 2028-07
Completion moved earlier: 2030-08 → 2030-06
Eligibility criteria+37 characters
Inclusion Criteria: All preterm infants born at or greater than 29 weeks' gestational age (29-36 weeks' GA) Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring FiO2 25% and qualify for LISA procedure Exclusion Criteria: Infants w [...]
Secondary endpointsdetails revised at 2 of 4 entries
2026-08-05
Study Status, Conditions, Arms and Interventions, Contacts/Locations v5
Recruitment opened
Start dateestimated 2026-08-04→confirmed 2026-08-05
Study sites0→1
2026-07-25
Study Status v4
Primary completion pushed: 2028-06 → 2028-09
Completion pushed: 2029-06 → 2030-08
Start date2026-06-01→2026-08-04
2026-02-02
Study Status v3
Primary completion date2028-03→2028-06
Completion date2029-02→2029-06
Start date2026-03-01→2026-06-01
2025-11-15
Study Identification, Study Status v2
Primary completion date2027-10→2028-03
Completion date2027-12→2029-02
Start date2025-10-01→2026-03-01
2025-06-26
Study Identification, Study Status, Contacts/Locations v1
Study title+31 characters
HelpingComparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants Breathe: Comparing Two Ways to Give Surfactant
2025-06-17
Original filing
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems than those who receive it using the LISA method. What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?
Trial Details
NCT Number NCT07030270
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Surfactant, Respiratory Distress Syndrome (Neonatal)
Enrollment 40 participants
Start Date 2026-08-05
Primary Completion 2028-07 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-16