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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
No Placebo-Only Group
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years of corrected gestational age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years of corrected gestational age
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 moreOther study objectives
Intubation, Intratracheal
Laryngoscopy attempt with the LISA procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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
562 Previous Clinical Trials
1,932,332 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Babies with known birth defects.I needed a breathing tube right after birth.
Research Study Groups:
This trial has the following groups:- Group 1: Less Invasive Surfactant Administration (LISA)
- Group 2: Continuous Positive Airway Pressure (CPAP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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