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

(CaLI Trial)

Not currently recruiting at 2 trial locations

Overseen By Felix Ines

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Sharp HealthCare

Disqualifiers: Congenital anomalies, Unstable birth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 23

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for premature babies with Neonatal Respiratory Distress Syndrome. Researchers aim to determine if administering a medicine called surfactant through a gentle method, known as Less Invasive Surfactant Administration (LISA), improves breathing more effectively than using Continuous Positive Airway Pressure (CPAP), a machine that keeps airways open. The goal is to reduce the need for more intense breathing support within the first three days of life. This trial targets babies born very early, between 24 to 29 weeks of pregnancy, who can breathe on their own with some CPAP assistance. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance care for premature babies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that the LISA method is safe for neonatal respiratory distress syndrome?

Research has shown that the Less Invasive Surfactant Administration (LISA) method is safe for newborns with breathing problems. Studies indicate that LISA can improve outcomes for premature babies. It is generally well-tolerated and has a good safety record, with fewer complications compared to methods like InSurE, which requires inserting a tube into the windpipe. These findings suggest LISA is a safe option for treating breathing issues in newborns.

Continuous Positive Airway Pressure (CPAP) is a widely used and safe method for helping newborns with breathing problems. CPAP gently keeps the baby's airways open, reducing the need for more invasive procedures. Both treatments have demonstrated safety, with LISA offering a less invasive alternative to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for neonatal respiratory distress syndrome because they offer less invasive options for helping newborns breathe. The Less Invasive Surfactant Administration (LISA) method delivers surfactant directly to the lungs without the need for intubation, using a small flexible catheter, which could reduce stress and potential complications for infants. Meanwhile, using Continuous Positive Airway Pressure (CPAP) early on can support babies' breathing by keeping their airways open, potentially avoiding the need for more invasive procedures. Both approaches aim to improve outcomes by minimizing interventions and supporting natural breathing in newborns.

What evidence suggests that this trial's treatments could be effective for neonatal respiratory distress syndrome?

Research has shown that the Less Invasive Surfactant Administration (LISA) method, a treatment in this trial, can significantly improve outcomes for newborns with respiratory distress syndrome (RDS). Studies have found that LISA reduces the need for mechanical breathing assistance in the first 72 hours after birth. This method involves administering a surfactant, a substance that helps keep the lungs open, directly into the baby's windpipe. Evidence suggests that LISA is safe and effective for premature babies. Meanwhile, Continuous Positive Airway Pressure (CPAP), another treatment option in this trial, is already a common method that helps keep the baby's airways open and eases breathing. Both treatments show promise for managing RDS, but LISA might reduce the need for more invasive procedures. ^{1 2 4 6 7}

Who Is on the Research Team?

Anup Katheria

Principal Investigator

Sharp HealthCare

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Treatment

Infants receive either LISA or CPAP treatment within the first 2 hours of life

72 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 months of corrected gestational age

Regular assessments until discharge

Long-term follow-up

Neurodevelopmental assessments using the Bayley Scales of Infant Development at 2 years of corrected age

Up to 2 years of corrected gestational age

Assessments at 22-26 months

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Positive Airway Pressure CPAP
• Less Invasive Surfactant Administration LISA

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.

How Is the Trial Designed?

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+

Loma Linda University

Collaborator

Trials

322

Recruited

267,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1875957224001165

Effectiveness and safety profile of introducing less invasive ... This study aimed to evaluate the effects of introducing LISA in the management of RDS on health outcomes and the safety profile.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11446307/

Less Invasive Surfactant Administration for Preterm Infants Caffeine and less invasive surfactant administration for respiratory distress syndrome of the newborn. ... Two-year outcome data suggest that less ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34515188/

Less-Invasive Surfactant Administration for Neonatal ... Conclusion: LISA has the potential to improve outcomes for preterm infants with RDS and can be introduced as a safe and effective part of UK-based neonatal care ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05711966

NCT05711966 | Comparison of INRECSURE and LISA in ... Recent-ly, a less invasive surfactant administration (LISA) method was developed with surfactant intro-duced into the trachea of infants breathing spontaneously ...

5. journals.lww.com journals.lww.com/jcma/fulltext/2020/02000/less_invasive_surfactant_administration_in_preterm.12.aspx

Less invasive surfactant administration in preterm infants... We found LISA procedure significantly reduced the incidence of invasive mechanical ventilation, not only before 72 hours after birth but also during the whole ...

6. nature.com nature.com/articles/s41372-024-02162-4

Outcomes, safety and health economics of introduction ... Less invasive surfactant administration (LISA) is associated with better outcomes than InSurE (Intubation-Surfactant ...

7. karger.com karger.com/neo/article/121/5/584/912456/Less-Invasive-Surfactant-Administration-for

Less Invasive Surfactant Administration for Preterm Infants Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol . BMJ Open . 2020.