Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration (LISA)-procedure in preterm infants. Secondary aims are to evaluate the effect of LISA on the general stress-level in preterm infants with respiratory distress syndrome. The assessment of pain and stress with SC measurement in addition to the subjective assessment with N-PASS may provide more conclusive data on the sensation of pain or stress during the LISA procedure and therefore the necessity of analgosedation. Therefore, this study might help to identify those infants in need for analgosedation, which would allow an individualized approach in the future.
Study Type
OBSERVATIONAL
Enrollment
21
SC will be measured using a specific monitor and three self-adhesive electrodes on one foot of the infant (one plantar and two on the ankles). Peaks per second (the rate of firing in the sympathetic nerves), average amplitude (mean peaks) and area under curve (forcefulness of sympathetic nerve firing) will be automatically analyzed. Corresponding data will be transferred to a separate tablet computer via bluetooth.
The video recording for later N-PASS assessment will be done by a camera fixed above the incubator / resuscitation unit, not interfering with the LISA procedure. The video will show the full body of the newborn as well as the hands / forearms of the treating clinical team with the awareness and oral consent of the treating team.
University Hospital Zurich
Zurich, Switzerland
Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline
The prespecified time-points are: 1. baseline: before starting of interventions (2 minutes recording without any intervention); 2. insertion of nasopharyngeal tube; 3. insertion of laryngoscope for visualization of the vocal cords; 4. insertion of LISA catheter 5. administration of surfactant 6. removal of catheter 7. 5 minutes after removal of catheter (2 minutes recording without any intervention) 8. 1 hour (±10 minutes) after LISA (2 minutes recording without any intervention)
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Median Neonatal Pain, Agitation and Sedation Scale (N-PASS) at prespecified time-points, adjusted for median N-PASS at baseline
The N-PASS serves as a tool for evaluating pain and sedation levels in newborns. In the context of this study, the focus is solely on assessing pain. Five criteria, including crying, behavior, facial expression, extremity tone and vital signs, are rated on a scale of 0 to 2 points each. These individual scores are then added up to calculate a total pain score, which falls within the range of 0 to 10. A higher total score correlates with a higher level of perceived pain. The prespecified time-points, at which the N-PASS will be assessed, are: 1. baseline: before starting of interventions 2. during insertion of laryngoscope for visualization of the vocal cords 3. administration of surfactant 4. 5 minutes after removal of catheter 5. 1 hour (±10 minutes) after LISA
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Absolute number of apneas
Absolute number of apneas requiring non-invasive pressure ventilation or increase of peak inspiratory pressure or frequency during the LISA procedure
Time frame: During LISA procedure
Absolute number of desaturations
Absolute number of decreasing SpO2 requiring increase of FiO2 during the LISA procedure
Time frame: During LISA procedure
Absolute number of bradycardia
Absolute number of bradycardia (\<100/min) during the LISA procedure
Time frame: During LISA procedure
Absolute number of arterial hypotension
Absolute number of arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure
Time frame: During LISA procedure
Absolute number of blunt surfactant reflux
Absolute number of blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure
Time frame: During LISA procedure
Difference in maximum peaks per second before and after apnea
Difference in maximum peaks per second before and after apnea requiring non-invasive pressure ventilation or increase of peak inspiratory pressure or frequency during the LISA procedure
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after apnea
Difference in median peaks per second during 20-second interval before and after apnea requiring non-invasive pressure ventilation or increase of peak inspiratory pressure or frequency during the LISA procedure
Time frame: During LISA procedure
Difference in maximum peaks per second before and after desaturation
Difference in maximum peaks per second before and after decreasing SpO2 requiring increase of FiO2 during the LISA procedure
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after desaturation
Difference in median peaks per second during 20-second interval before and after decreasing SpO2 requiring increase of FiO2 during the LISA procedure
Time frame: During LISA procedure
Difference in maximum peaks per second before and after bradycardia
Difference in maximum peaks per second before and after bradycardia (\<100/min) during the LISA procedure
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after bradycardia
Difference in median peaks per second during 20-second interval before and after bradycardia (\<100/min) during the LISA procedure
Time frame: During LISA procedure
Difference in maximum peaks per second before and after arterial hypotension
Difference in maximum peaks per second before and after arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after arterial hypotension
Difference in median peaks per second during 20-second interval before and after arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure
Time frame: During LISA procedure
Difference in maximum peaks per second before and after blunt surfactant reflux
Difference in maximum peaks per second before and after blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux
Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure
Time frame: During LISA procedure
Difference in heart-rate between baseline and prespecified time-points as listed above.
Difference in heart-rate between baseline and prespecified time-points as listed above 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference in oxygen saturation between baseline and prespecified time-points as listed above.
Difference in oxygen saturation between baseline and prespecified time-points as listed above 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above.
Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference of SpO2/FiO2-ratio compared to skin conductance peaks per second
Difference of SpO2/FiO2-ratio at baseline, 5 minutes after removal of catheter and 60 minutes after LISA compared to skin conductance peaks per second (median peaks per second of 2 minute intervals).
Time frame: 2 minutes before LISA, 5 minutes after removal of catheter, 60 Minutes after LISA
LISA failure
Incidence of LISA failure defined as intubation or repeated LISA within 24 hours
Time frame: Within 24 hours after LISA
Intubation <72 hours after the LISA procedure
Incidence of intubation within \<72 hours after the LISA procedure
Time frame: Within 72 hours after LISA
Air-leaks <72 hours after the LISA procedure
Incidence of air-leaks within \<72 hours after the LISA procedure
Time frame: Within 72 hours after LISA
Incidence of intraventricular hemorrhage
Incidence of intraventricular hemorrhage at first ultrasound scan after 72 hours
Time frame: 72 hours after LISA
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