What side effects are associated with this type of intervention?

Common treatments for Respiratory Distress Syndrome (RDS), such as surfactant therapy, can have side effects including transient bradycardia, oxygen desaturation, and airway obstruction. There are also risks of pulmonary hemorrhage and infection. The Less Invasive Surfactant Administration (LISA) method aims to reduce these risks by minimizing the need for mechanical ventilation.

What prior FDA approvals exist?

The FDA has approved several surfactant therapies for the treatment of Respiratory Distress Syndrome (RDS). These include drugs like Survanta (beractant), Curosurf (poractant alfa), and Infasurf (calfactant). These surfactants work by reducing surface tension in the lungs, which helps keep the air sacs open and improves oxygenation. The LISA method, which is currently under investigation, aims to administer these surfactants in a less invasive manner, potentially reducing the need for mechanical ventilation in preterm infants.

What other types of research exist?

Promising novel alternatives to the Surfactant (LISA method) for treating Respiratory Distress Syndrome (RDS) in 2024 include: 1) Conservative fluid management strategies, which have shown benefits in improving oxygenation and increasing ventilator-free and ICU-free days. 2) Glucocorticoid therapy, which has demonstrated a probable mortality benefit in some trials, especially when combined with low tidal volume ventilation. 3) Inhaled steroids, such as budesonide, which are currently under investigation for their potential benefits in RDS. These alternatives focus on optimizing fluid balance, reducing inflammation, and improving overall lung function in RDS patients.

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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 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 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

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

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).

0 / 3Eligibility criteria met

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.