Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715373
Status:
RECRUITING
Last Update Posted:
2023-08-22
First Post:
2021-01-13
Brief Title:
LISA in the Delivery Room for Extremely Preterm Infants
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Less Invasive Administration of Surfactant in the Delivery Room for Extremely Preterm Infants A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRLISA
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 03 Infants requiring CPAP 7 at FiO2 03 will receive LISA CPAP will be titrated between 5-8 cm H20 after LISA
Infants in both arms requiring CPAP 7 and FiO2 08 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 06 for 1 hour apnea requiring stimulation 3 times within one hour or 6 over 6 hour period any apnea requiring PPV or CO2 065 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
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 03 Infants requiring CPAP 7 at FiO2 03 will receive LISA CPAP will be titrated between 5-8 cm H20 after LISA
Infants in both arms requiring CPAP 7 and FiO2 08 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 06 for 1 hour apnea requiring stimulation 3 times within one hour or 6 over 6 hour period any apnea requiring PPV or CO2 065 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
Detailed Description:
This is a single center unblinded randomized control feasibility trial to evaluate the use of LISA in the DR for extremely preterm infants born 22-25 weeks GA who were successfully resuscitated without being intubated The study team will approach a mother who is at risk of delivering an infant between 22-25 week GA for consent to be included in the study Infants will be resuscitated according to NRP algorithm Infants who are successfully resuscitated without requiring intubation and mechanical ventilation HR 100 regular spontaneous respiratory effort able to maintain oxygenation per NRP target saturation goal are eligible for enrollment Randomization will be achieved by opening an opaque envelope
Intervention arm DR-LISA Infants with a stable heart rate and spontaneous respiratory effort on CPAP are eligible for surfactant therapy A LISA catheter will be prepared for use prior to the birth of the infant Surfactant will be drawn into a syringe soon after the initial stabilization A trained physician will perform LISA The infant will be maintained on CPAP by prongs during the procedure PPV will be provided if needed after the procedure The infant will be monitored in the DR for stable HR respiration and SpO2 prior to being moved to a transporter Infants requiring FiO2 08 on CPAP 8 cm H2O to maintain SpO2 88-94 by 20 minutes of life will be intubated prior to transport After admission to NICU CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold 03
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 CPAP level be titrated between 5- 7 cm H2O in the DR Infants requiring FiO2 08 to maintain SpO2 88-94 by 20 minutes of life will be intubated in DR 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 03 CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold 03 Infants in both groups who require FiO2 06 for 1 hour apnea requiring stimulation 3 times within one hour or 6 over 6 hour period any apnea requiring PPV or CO2 065 in two consecutive blood gases drawn over two hours will be considered as reasons for intubation after LISA
Repeat doses of surfactant will be administered every 12 hours for FiO2 04 up to a maximum of three doses
Intervention arm DR-LISA Infants with a stable heart rate and spontaneous respiratory effort on CPAP are eligible for surfactant therapy A LISA catheter will be prepared for use prior to the birth of the infant Surfactant will be drawn into a syringe soon after the initial stabilization A trained physician will perform LISA The infant will be maintained on CPAP by prongs during the procedure PPV will be provided if needed after the procedure The infant will be monitored in the DR for stable HR respiration and SpO2 prior to being moved to a transporter Infants requiring FiO2 08 on CPAP 8 cm H2O to maintain SpO2 88-94 by 20 minutes of life will be intubated prior to transport After admission to NICU CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold 03
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 CPAP level be titrated between 5- 7 cm H2O in the DR Infants requiring FiO2 08 to maintain SpO2 88-94 by 20 minutes of life will be intubated in DR 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 03 CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold 03 Infants in both groups who require FiO2 06 for 1 hour apnea requiring stimulation 3 times within one hour or 6 over 6 hour period any apnea requiring PPV or CO2 065 in two consecutive blood gases drawn over two hours will be considered as reasons for intubation after LISA
Repeat doses of surfactant will be administered every 12 hours for FiO2 04 up to a maximum of three doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None