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Early Caffeine + LISA vs. CPAP for Neonatal Respiratory Distress Syndrome (CaLI Trial)

N/A
Waitlist Available
Led By Anup Katheria
Research Sponsored by Sharp HealthCare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infant is spontaneously breathing on CPAP of 5-8 cmH2O and maintaining a normal heart rate (HR>100 Bpm)
Premature infants born at 24 to 29+6 weeks gestation
Must not have
Unstable immediately after birth, requiring intubation in the delivery room
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years of corrected gestational age
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from CPAP masks or nasal prongs, irritation in airways from LISA procedure, and general risks associated with handling preterm infants such as infections or delayed growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My infant breathes on their own with CPAP support and has a normal heart rate.
Select...
My baby was born prematurely between 24 and just under 30 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I needed a breathing tube right after birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years of corrected gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years of corrected gestational age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intubation, Intratracheal
Secondary study objectives
Duration of mechanical ventilation and/or CPAP
Frequency of Grade III and IV intraventricular hemorrhage
Need for repeat surfactant dosing
+3 more
Other study objectives
Intubation, Intratracheal
Laryngoscopy attempt with the LISA procedure

Trial Design

2Treatment groups
Active Control
Group I: Less Invasive Surfactant Administration (LISA)Active Control1 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 Control1 Intervention
Infants that are spontaneously breathing with a normal heart rate will be randomized to early Continuous Positive Airway Pressure (CPAP).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Respiratory Distress Syndrome (RDS) include surfactants, glucocorticoids, and fluid management strategies. Surfactants, like those administered via the Less Invasive Surfactant Administration (LISA) method, reduce surface tension in the lungs, helping to keep the alveoli open and improve gas exchange. Glucocorticoids reduce lung inflammation, enhancing lung function and oxygenation. Fluid management strategies aim to maintain an optimal fluid balance to prevent fluid overload, which can impair lung function. These treatments are essential for RDS patients as they address the critical issues of poor oxygenation and lung function, which are vital for survival and recovery.
Prevention or Treatment of Ards With Aspirin: A Review of Preclinical Models and Meta-Analysis of Clinical Studies.A Search for subgroups of patients with ARDS who may benefit from surfactant replacement therapy: a pooled analysis of five studies with recombinant surfactant protein-C surfactant (Venticute).Mechanical ventilation and adjuncts in acute respiratory distress syndrome.

Find a Location

Who is running the clinical trial?

Sharp HealthCareLead Sponsor
40 Previous Clinical Trials
16,991 Total Patients Enrolled
1 Trials studying Respiratory Distress Syndrome
80 Patients Enrolled for Respiratory Distress Syndrome
Sharp Mary Birch Hospital for Women & NewbornsOTHER
12 Previous Clinical Trials
6,389 Total Patients Enrolled
University of California, IrvineOTHER
559 Previous Clinical Trials
1,929,943 Total Patients Enrolled

Media Library

Continuous Positive Airway Pressure CPAP Clinical Trial Eligibility Overview. Trial Name: NCT04209946 — N/A
Respiratory Distress Syndrome Research Study Groups: Less Invasive Surfactant Administration (LISA), Continuous Positive Airway Pressure (CPAP)
Respiratory Distress Syndrome Clinical Trial 2023: Continuous Positive Airway Pressure CPAP Highlights & Side Effects. Trial Name: NCT04209946 — N/A
Continuous Positive Airway Pressure CPAP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209946 — N/A
~6 spots leftby Jan 2025