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Early Caffeine and LISA Compared to Caffeine and CPAP in Preterm Infants

NCT04209946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Premature Lungs
  • Respiratory Distress Syndrome
  • Surfactant Deficiency Syndrome Neonatal

Interventions

PROCEDURE

Less Invasive Surfactant Administration LISA

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

PROCEDURE

Continuous Positive Airway Pressure CPAP

Infant will remain on CPAP Therapy during spontaneous respirations

Sponsors & Collaborators

  • Sharp Mary Birch Hospital for Women & Newborns

    collaborator OTHER

  • Loma Linda University

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • Anup Katheria · Sharp HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2023-05-08
Completion
2025-11-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04209946 on ClinicalTrials.gov