LISA for Premature Birth
(DRLISA Trial)
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?
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.678910
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Infants receive LISA in the delivery room or NICU based on randomization, with CPAP titration and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including need for mechanical ventilation and other outcomes
Extended Follow-up
Monitoring for long-term outcomes such as bronchopulmonary dysplasia and other complications until hospital discharge or 6 months of life
Treatment Details
Interventions
- LISA
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Chiesi USA, Inc.
Industry Sponsor