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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

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Need for intubation and/any mechanical ventilation

Secondary study objectives

Bronchopulmonary dysplasia

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

High Frequency Ventilation

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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