Early Caffeine + LISA vs. CPAP for Neonatal Respiratory Distress Syndrome

(CaLI Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Anup Katheria

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sharp HealthCare

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if giving a special liquid called surfactant to preterm babies using a gentle method can reduce the need for a breathing machine. The study focuses on babies born very early who are already getting some breathing support. The surfactant helps keep their lungs open, making it easier to breathe. Surfactant therapy has been a major contribution to the care of preterm newborns over the years.

Research Team

Anup Katheria

Principal Investigator

Sharp HealthCare

Eligibility Criteria

This trial is for premature infants born between 24 and just under 30 weeks of gestation. They must be breathing on their own with CPAP support and have a normal heart rate. Infants can't join if they have birth defects, didn't get parental consent, or needed intubation right after birth due to instability.

Inclusion Criteria

My infant breathes on their own with CPAP support and has a normal heart rate.

My baby was born prematurely between 24 and just under 30 weeks.

Informed consent obtained (antenatal)

Exclusion Criteria

Babies with known birth defects.

I needed a breathing tube right after birth.

Declined consent

Treatment Details

Interventions

• Continuous Positive Airway Pressure CPAP (Procedure)
• Less Invasive Surfactant Administration LISA (Surfactant)

Trial Overview The study compares two treatments for preterm lung problems: one group receives surfactant through the Less Invasive Surfactant Administration (LISA) method, while the other gets early Continuous Positive Airway Pressure (CPAP) alone to see which reduces mechanical ventilation need within the first 72 hours of life.

Participant Groups

Group I: Less Invasive Surfactant Administration (LISA) Active Control 1 Intervention

Infants that are spontaneously breathing with a normal heart rate will be randomized to receive prophylactic surfactant (Curosurf 2.5 mL/kg, based on estimated fetal weight) by the LISA procedure in the first 2 hours of life, using a conventional or video laryngoscope and a small flexible 16 gauge angiocatheter. Any repeat dosing for surfactant will be based on clinical indication at the physician discretion by the conventional endotracheal approach.

Group II: Continuous Positive Airway Pressure (CPAP) Active Control 1 Intervention

Infants that are spontaneously breathing with a normal heart rate will be randomized to early Continuous Positive Airway Pressure (CPAP).

Who Is Running the Clinical Trial?

Sharp HealthCare

Lead Sponsor

Trials

42

Recruited

17,600+

Sharp Mary Birch Hospital for Women & Newborns

Collaborator

Trials

13

Recruited

6,600+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Chad T. Lefteris

University of California, Irvine

Chief Executive Officer since 2019

MBA from University of California, Irvine

Michael J. Stamos

University of California, Irvine

Chief Medical Officer since 2019

MD, PhD from University of California, Irvine

Loma Linda University

Collaborator

Trials

322

Recruited

267,000+

Adrian Cotton

Loma Linda University

Chief Medical Officer since 2020

MD

Richard H. Hart

Loma Linda University

Chief Executive Officer since 2015

MD, DrPH