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Procedure

LISA for Premature Birth (DRLISA Trial)

N/A

Recruiting

Led By Venkatakrishna Kakkilaya, MBBS

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants born 22 -25 weeks GA

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until hospital discharge or 6 months of life

Awards & highlights

DRLISA Trial Summary

This trial is testing whether or not using LISA in the delivery room decreases the intubation rates in preterm infants at 23-25 weeks gestational age, during first 72 hours compared to the standard approach of stabilization on nasal CPAP in the DR.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, procedures like LISA may cause discomfort or breathing difficulties and there's always a risk of infection or injury from medical interventions in such fragile patients.

DRLISA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

DRLISA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until hospital discharge or 6 months of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until hospital discharge or 6 months of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and until hospital discharge or 6 months of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Need for intubation and/any mechanical ventilation

Secondary outcome measures

Bronchopulmonary dysplasia

Desaturation (SpO2 <80) and Bradycardia (HR <100) events

High Frequency Ventilation

+6 more

DRLISA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DR-LISAExperimental Treatment1 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-LISAActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LISA

2013

N/A

~60

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,715 Total Patients Enrolled

5 Trials studying Premature Birth

4,136 Patients Enrolled for Premature Birth

Chiesi USA, Inc.Industry Sponsor

8 Previous Clinical Trials

6,044 Total Patients Enrolled

1 Trials studying Premature Birth

200 Patients Enrolled for Premature Birth

Venkatakrishna Kakkilaya, MBBSPrincipal InvestigatorUT Southwestern Medical Center

Media Library

LISA (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04715373 — N/A

Premature Birth Research Study Groups: NICU-LISA, DR-LISA

Premature Birth Clinical Trial 2023: LISA Highlights & Side Effects. Trial Name: NCT04715373 — N/A

LISA (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04715373 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort participating in this clinical trial?

"Affirmative. Per the information posted on clinicaltrials.gov, this medical study is still accepting patients for enrollment as of June 29th 2022. The trial was first available to view from June 22nd 2021 and requires 60 individuals across one site."

Answered by AI

To what demographic is participation in this research endeavor available?

"This trial is seeking 60 infants suffering from respiratory distress syndrome that were born between 23 and 25 weeks gestation. To be eligible, they must have been successfully resuscitated without intubation, maintain a heart rate of over 100 beats per minute, achieve oxygen saturation within the parameters set out by NRP guidelines and show regular breathing efforts while on CPAP therapy."

Answered by AI

Are fresh applicants still being accepted for this clinical experiment?

"Consistent with the data available on clinicaltrials.gov, this medical examination is actively recruiting participants, having first been posted on June 22nd 2021 and edited most recently on June 29th 2022."

Answered by AI