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

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment LISA for premature birth?

Research shows that using LISA (less invasive surfactant administration) in preterm infants can reduce the need for mechanical ventilation and lower the risk of complications like bronchopulmonary dysplasia (a lung condition) and intraventricular hemorrhage (bleeding in the brain). ^{1 2 3 4 5}

How does the LISA treatment for premature birth differ from other treatments?

LISA (Less Invasive Surfactant Administration) is unique because it delivers surfactant directly into the lungs of premature infants using a thin tube, avoiding the need for mechanical ventilation. This method is less invasive and can reduce the risk of lung injury compared to traditional methods that require intubation and mechanical ventilation. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 hours compared to the standard approach of stabilization on nasal CPAP in the DR and administering surfactant in the NICU. Infants in both groups will be resuscitated per NRP algorithm. Infants who maintain a stable HR and respiratory effort on CPAP will qualify for the intervention. Infants in Group 1 (Intervention arm) will receive LISA in DR. CPAP will be titrated between 5-8 cm H20 after LISA. Infants in Group 2 (Control arm) will be transferred to NICU on CPAP. The CPAP level will be increased stepwise every 30 minutes to 7 cm H2O if FiO2 ≥0.3. Infants requiring CPAP 7 at FiO2 ≥0.3 will receive LISA. CPAP will be titrated between 5-8 cm H20 after LISA. Infants in both arms requiring CPAP 7 and FiO2 \>0.8 at 20 MOL in the delivery room will be intubated in DR. Any infant with a heart rate not responding with appropriate PPV will be intubated in the DR. CXR will be obtain on admission and umbilical lines will be placed. Infants in both arm who require FiO2 ≥0.6 for ≥1 hour, apnea requiring stimulation 3 times within one hour or ≥6 over 6 hour period, any apnea requiring PPV, or CO2 \>0.65 in two consecutive blood gases drawn over two hours will be considered as reasons for intubation after LISA. Primary outcome is the need for MV within 72 hours of life, secondary outcome includes need for MV during first week of life and during hospital stay, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), need for treatment of patent ductus arteriosus (PDA), composite death or BPD and mortality. This is a feasibility trial with the intention to enroll 30 infants in each arm of the study over three years.

Research Team

Venkatakrishna Kakkilaya, MBBS

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Cost-saving effect of early less invasive surfactant administration versus continuous positive airway pressure therapy alone for preterm infants with respiratory distress syndrome. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Association of Administration of Surfactant Using Less Invasive Methods With Outcomes in Extremely Preterm Infants Less Than 27 Weeks of Gestation. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Born too soon: the continuing challenge of preterm labor and birth in the United States. [2008]

5. Australia pubmed.ncbi.nlm.nih.gov

Experience of less invasive surfactant administration with a 5F infant feeding tube in a tertiary center of low- and middle-income countries. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The outcome of extreme prematurity. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Mid and long-term neurological prognosis of preterm infants less than 28 weeks gestational age]. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

[Recommendations for the prevention of respiratory syncytial virus infections. Standards Committee of the Spanish Society of Neonatology. Board of Directors of the Spanish Society of Neonatology]. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Ambiguous loss and post-traumatic growth: Experiences of mothers whose school-aged children were born extremely prematurely. [2018]

10. Chile pubmed.ncbi.nlm.nih.gov

[Survival, viability and prognosis of premature infant]. [2018]