Respiratory Distress Syndrome Clinical Trial
— DRLISAOfficial title:
Less Invasive Administration of Surfactant in the Delivery Room for Extremely Preterm Infants: A Randomized Control 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Minutes to 20 Minutes |
Eligibility | Inclusion Criteria: - Infants born 22 -25 weeks GA - Resuscitated without requiring intubation and maintaining HR >100, oxygen saturation per NRP goal saturation limits and regular respiratory effort on CPAP Exclusion Criteria: - Major congenital anomalies |
Country | Name | City | State |
---|---|---|---|
United States | Venkatakrishna Kakkilaya | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Chiesi USA, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for intubation and/any mechanical ventilation | Any Infant randomized to the study requiring intubation and/mechanical ventilation | within 72 hours of life | |
Secondary | Need for mechanical ventilation within 7 days of life | Any Infant randomized to the study requiring intubation and/mechanical ventilation | Within 7 days of life. | |
Secondary | Mechanical Ventilation | Any infant requiring MV | Until hospital discharge or 6 months of life | |
Secondary | High Frequency Ventilation | Any infant requiring high frequency ventilation | Until hospital discharge or 6 months of life | |
Secondary | Mechanical ventilator days | Infant requiring MV for longer than 12 hours in a day | Until hospital discharge or 6 months of life | |
Secondary | Bronchopulmonary dysplasia | Infant requiring supplemental oxygen at 36 weeks PMA | Until hospital discharge or 6 months of life | |
Secondary | Severe intraventricular hemorrhage | Grade 3 or 4 intraventricular hemorrhage | Until hospital discharge or 6 months of life | |
Secondary | Pneumothorax | Radiographic evidence of pneumothorax | Until hospital discharge or 6 months of life | |
Secondary | Desaturation (SpO2 <80) and Bradycardia (HR <100) events | Any desaturation and bradycardia event lasting >10 seconds during LISA procedure | During the first 72 hours | |
Secondary | Proportion of infants requiring >1 LISA attempt | Any direct laryngoscopy attempt | During the first 72 hours of life |
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