Premedication for Less Invasive Surfactant Administration Study (PRELISA)

University of Texas Southwestern Medical Center58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interventions

IV Atropine and Fentanyl Premedication ArmDRUG

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.

IV Normal Saline Placebo ArmDRUG

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.

Outcomes

Primary Outcomes

Number of bradycardia and hypoxemia events during 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

Time frame: Time of medication infusion to completion of LISA procedure

Secondary Outcomes

Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55%

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

Time frame: From time of start of LISA procedure to 12 hours after procedure

Procedure first attempt success rate

* 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.

Time frame: At time of LISA procedure

Intubation rate

* 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.

Time frame: Within 24 hours after LISA procedure

Mean number of attempts required

Procedure attempt defined as introduction of laryngoscope blade into the mouth

Time frame: At time of LISA procedure

Mean duration of bradycardia and hypoxemia events

* 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