LISA for Premature Birth

(DRLISA Trial)

Overseen By Christina M Chan, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Major congenital anomalies

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a treatment called LISA (a method to assist breathing) in the delivery room can reduce the need for more invasive breathing support in very premature infants born at 22-25 weeks. It compares two groups: one receiving LISA immediately in the delivery room, and the other receiving standard care, with the possibility of LISA later in the NICU (intensive care for newborns). The researchers seek to understand if LISA can decrease the need for mechanical ventilation (machines that assist with breathing) in the first few days of life. Suitable candidates for this trial are infants born between 22-25 weeks who can breathe independently with light support immediately after birth. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance care for very premature infants.

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 this method is safe for preterm infants?

Research has shown that the Less Invasive Surfactant Administration (LISA) method is generally safe for premature babies. Studies have found that LISA is well-tolerated, with few reports of negative side effects. Specifically, data from previous studies over two years suggest that LISA does not significantly harm infants.

One study compared premature babies who received LISA with those treated using other methods. This research found no major safety concerns with LISA, suggesting it is a good option for managing breathing problems in newborns.

Overall, the safety data appear promising. However, discussing potential risks and benefits with healthcare providers before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LISA (Less Invasive Surfactant Administration) for premature birth because it offers a gentler way to deliver surfactant to infants with respiratory distress. Unlike traditional methods that require intubation, LISA uses a thin catheter to administer surfactant directly into the lungs while the baby continues to breathe on their own. This approach minimizes the need for mechanical ventilation, which can be stressful and risky for premature infants. By potentially reducing complications associated with intubation, LISA could improve outcomes for these vulnerable newborns.

What evidence suggests that LISA is effective for reducing intubation rates in preterm infants?

Research has shown that Less Invasive Surfactant Administration (LISA) holds promise for premature babies. In this trial, participants will be assigned to one of two treatment arms: NICU-LISA or DR-LISA. Studies have found that LISA, which involves administering a liquid to help the lungs expand more easily, can reduce the need for breathing machines. For babies born prematurely, this method has been linked to better outcomes, such as fewer breathing problems and a lower risk of lung damage. Additionally, LISA is considered safe and less stressful for infants compared to traditional methods. Overall, evidence supports LISA as an effective treatment for improving lung function in premature babies. ^{1 2 3 4 5}

Who Is on the Research Team?

Venkatakrishna Kakkilaya, MBBS

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for extremely preterm infants born between 22-25 weeks gestational age who can breathe with some assistance but don't need immediate intubation. They should have a stable heart rate and oxygen levels within the normal range on CPAP (a type of breathing support). Infants with major birth defects cannot participate.

Inclusion Criteria

My baby was born between 22 and 25 weeks of pregnancy.

I was revived without needing a breathing tube and maintain a heart rate over 100, proper oxygen levels, and normal breathing on CPAP.

Exclusion Criteria

You were born with a major physical abnormality.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Infants receive LISA in the delivery room or NICU based on randomization, with CPAP titration and monitoring

72 hours

Continuous monitoring in the delivery room and NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including need for mechanical ventilation and other outcomes

7 days

Extended Follow-up

Monitoring for long-term outcomes such as bronchopulmonary dysplasia and other complications until hospital discharge or 6 months of life

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• LISA

Trial Overview The study tests if LISA, a method to deliver surfactant without intubation, in the delivery room reduces the need for mechanical ventilation in the first 72 hours compared to standard care. Half will receive LISA immediately; others get it only if needed after transfer to NICU.

How Is the Trial Designed?

Group I: DR-LISA Experimental Treatment 1 Intervention

Experimental: Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs. A trained physician will perform LISA using Hobart method. Infants requiring FiO2 \>0.8 on CPAP 8 cm H2O to maintain SpO2 88-94% by 20 minutes of life will be intubated prior to transport. After admission to the NICU, CPAP will be titrated 5-8 cm H20.

Group II: NICU-LISA Active Control 1 Intervention

Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs and transported to NICU on CPAP. After admission to NICU, CPAP will be escalated every 30 minutes up to a maximum level of 7 cm H2O at which point infant would qualify for LISA if the FiO2 requirement is ≥0.3. LISA will be performed using Hobart method. Infants requiring FiO2 \>0.8 to maintain SpO2 88-94% by 20 minutes of life will be intubated in the DR.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Chiesi USA, Inc.

Industry Sponsor

Trials

9

Recruited

6,100+

Citations

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

Less Invasive Surfactant Administration for Preterm Infants Two-year outcome data suggest that less invasive surfactant administration (LISA) is safe. Results from the follow-up of the randomized ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2809514

Two-Year Outcomes After Minimally Invasive Surfactant ... Two-year outcomes after minimally invasive surfactant therapy in preterm infants: follow-up of the OPTIMIST-A randomized clinical trial.

3. 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.

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

Outcomes, safety and health economics of introduction ... We compared outcomes of premature infants who received surfactant via VL-assisted LISA (January 2021–December 2021) with infants who had ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06421506

Less Invasive Surfactant Administration in Late Preterm or ... The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the ...