LISA in the Delivery Room for Extremely Preterm Infants

NCT04715373 | Completed DMC

• 1 other identifier: STU-2020-0926
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extreme Prematurity; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Need for intubation and/any mechanical ventilation

  Any Infant randomized to the study requiring intubation and/mechanical ventilation

  within 72 hours of life

Secondary Outcomes (10)

• Need for mechanical ventilation within 7 days of life

  Within 7 days of life.

• Mechanical Ventilation

  Until hospital discharge or 6 months of life

• High Frequency Ventilation

  Until hospital discharge or 6 month of life

• Mechanical ventilator days

  Until hospital discharge or 6 months of life

• Bronchopulmonary dysplasia

  Until hospital discharge or 6 months of life

Study Arms (2)

DR-LISA

EXPERIMENTAL

Experimental: Group 1: (Intervention Arm) 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. Infant will be maintained on CPAP by prongs during the procedure. . PPV will be provided if needed after the procedure. 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 H2O.

Procedure: LISA

NICU-LISA

ACTIVE COMPARATOR

Group 2: Control Arm 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. Infants requiring FiO2 \>0.8 to maintain SpO2 88-94% by 20 minutes of life will be intubated in the DR.

Procedure: LISA

Interventions

LISA PROCEDURE

LISA administered in the DR after initial resuscitation or in the NICU after stepwise escalation of CPAP based on FiO2 ≥0.3. While maintaining infant on CPAP with binasal prongs/small nasal mask, a thin catheter (Hobart method) is inserted below the vocal cord using direct laryngoscopy. Poractant alfa (200mg/kg) is administered slowly over 2-3 minutes. Catheter is then withdrawn and infant is maintained on CPAP

DR-LISA; NICU-LISA

Eligibility Criteria

• Age: 5 Minutes - 20 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born 22 -25 weeks GA
• Resuscitated without requiring intubation and maintaining HR \>100, and spontaneous respiratory effort on CPAP 5-7 cm H2O)

You may not qualify if:

• Major congenital anomalies
• Infants receiving only comfort care
• Mothers with impaired decision making capacity

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Chiesi USA, Inc.: collaborator

Study Sites (1)

Venkatakrishna Kakkilaya

Dallas, Texas, 75093, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Venkatakrishna Kakkilaya, MBBS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: June 22, 2021
• Primary Completion: December 10, 2024
• Study Completion: April 8, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)