Respiratory Distress Syndrome, Newborn
Conditions
Keywords
Premedication for Less Invasive Surfactant Administration, Fentanyl and Atropine for Less Invasive Surfactant Administration, Cerebral Near Infrared Spectroscopy monitoring in neonates, Premedication for LISA, Fentanyl and Atropine for LISA, Cerebral NIRS monitoring in neonates
Brief summary
The purpose of this study is to conduct a double blinded randomized control trial to determine the safety and efficacy of using IV fentanyl and atropine prior to Less Invasive Surfactant Administration (LISA) procedure in preterm infants with Respiratory Distress Syndrome compared to the local standard of care to perform this procedure without any premedication. Hypothesis: In infants greater than or equal to 29 weeks gestational age requiring the Less Invasive Surfactant Administration procedure, premedication with a combination of IV atropine and IV fentanyl will be associated with fewer combined bradycardia events, defined as heartrate less than 100 beats per minute for longer than 10 seconds, and hypoxemia events, defined as saturations less than or equal to 80% for longer than 30 seconds, during the procedure compared with placebo. Specific Aims: * To determine if infants ≥29 week GA receiving IV fentanyl and atropine prior to LISA will have a decrease in hypoxemia and bradycardia events during the procedure compared to infants receiving placebo * To determine if infants ≥29 week GA receiving premedication prior to Less Invasive Surfactant Administration will have higher procedure first attempt success rate compared with infants receiving placebo * To determine the effect of premedication on cerebral oxygenation compared to placebo during and for 12 hours after Less Invasive Surfactant Administration in infants ≥29 week GA using cerebral Near Infrared Spectroscopy. * To determine the effect of premedication prior to Less Invasive Surfactant Administration on the need for mechanical ventilation during ≤72 hours of life in preterm infants.
Interventions
DRUGIV Atropine and Fentanyl Premedication Arm
Prior to the LISA procedure, the blinded bedside nurse will infuse IV Atropine, labelled as "Atropine/Placebo," over 1 minute, followed by IV fentanyl, labelled as "Fentanyl/Placebo," over 20 minutes in the presence of blinded respiratory therapist and primary team provider. After medication infusion, a primary team member will perform Less Invasive Surfactant Administration procedure. Infant vital signs, cerebral Near Infrared Spectroscopy values, pain scores will be monitored and recorded during and for 12 hours after the procedure. Level of respiratory support, oxygen requirement and subsequent need for intubation for 24 hours after the procedure will be obtained from the electronic medical record.
DRUGIV Normal Saline Placebo Arm
Prior to the Less Invasive Surfactant Administration procedure, the blinded bedside nurse will infuse IV Normal Saline, labelled as "Atropine/Placebo," over 1 minute, followed by a second infusion of IV Normal Saline, labelled as "Fentanyl/Placebo," over 20 minutes in the presence of blinded respiratory therapist and primary team provider. After Normal Saline infusion, primary team member will perform Less Invasive Surfactant Administration procedure. Infant vital signs, cerebral Near Infrared Spectroscopy values, pain scores will be monitored and recorded during and for 12 hours after the procedure. Level of respiratory support, oxygen requirement and subsequent need for intubation for 24 hours after the procedure will be obtained from the electronic medical record.
Sponsors
University of Texas Southwestern Medical Center
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Quadruple Blinded
Eligibility
Sex/Gender
ALL
Age
0 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Infants ≥29 weeks gestational age initiated on CPAP in the delivery room or upon admission who require ≥0.25 FiO2.
Exclusion criteria
* Infants requiring intubation prior to surfactant therapy * Infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies) * Infants born to mothers with known opioid addiction or in a methadone treatment program * Maternal COVID19 infection (RT-PCR positive) within two weeks prior to delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of bradycardia and hypoxemia events during LISA procedure | Time of medication infusion to completion of LISA procedure | * Bradycardia events will be defined as heartrate \<100 beats per minute for \>10 seconds. Heartrate will be obtained from the participant's heartrate monitor. * Hypoxemia events will be defined as participant saturation (SpO2) =\<80% for \>30 seconds. SpO2 will be obtained from the participant's pulse oximeter monitor. * Events will be recorded by the respiratory therapist and/ or bedside nurse present during the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55% | From time of start of LISA procedure to 12 hours after procedure | Cerebral NIRS is a method of noninvasively monitoring cerebral oxygenation. The probes detect a value every 6 seconds and display onto the monitor. Scores between 55-80% are considered within the normal range. Scores less than 55% are considered suboptimal cerebral oxygenation. * Percent of time spent with low NIRS values \<55% during the 12 hour observation period will be calculated |
| Procedure first attempt success rate | At time of LISA procedure | * Procedure attempt is defined as introduction of laryngoscope blade into the mouth. * Procedure success is defined by ability to insert catheter and administer surfactant, without surfactant aspirated from the stomach after administration. * Rate will be calculated as a percent of participants in each arm. |
| Intubation rate | Within 24 hours after LISA procedure | * Rate will be calculated as a percent of participants in each group. * Participants need for and timing of intubation will be obtained from electronic medical record. |
| Mean number of attempts required | At time of LISA procedure | Procedure attempt defined as introduction of laryngoscope blade into the mouth |
| Mean duration of bradycardia and hypoxemia events | Time of medication infusion to completion of LISA procedure | * Bradycardia events will be defined as heartrate \<100 beats per minute for \>10 seconds. Heartrate will be obtained from the participant's heartrate monitor. * Hypoxemia events will be defined as participant saturation (SpO2) =\<80% for \>30 seconds. SpO2 will be obtained from the participant's pulse oximeter monitor. * Duration of events in seconds will be recorded by the respiratory therapist and/ or bedside nurse present during the procedure |
Countries
United States
Contacts
STUDY_DIRECTORVenkatakrishna Kakkilaya, MD
University of Texas Southwestern Medical Center
Outcome results
None listed