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Completed

NCT Number: NCT06150586

Pain Assessment During Less-Invasive-Surfactant-Administration

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Lung Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pulmonary Atelectasis Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Signs and Symptoms Stress Surfactant Deficiency Syndrome Neonatal

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, CH-8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants ≥27 0/7 weeks of gestation at birth
  • Need for surfactant therapy via LISA according to the local standard operating procedure
  • ≥27 0/7 weeks of gestation,
  • within first 48 hours of life
  • FiO2 ≥0.30 to maintain SpO2 ≥90% for 15 min,
  • non-invasive respiratory support with PEEP 6-8 cmH2O
  • consent of attending NICU staff for videorecording

Exclusion criteria

  • Primary intubation in the delivery room
  • Severe congenital malformation or other conditions requiring immediate endotracheal intubation
  • Insufficient language skills (German or English) of the parents to understand and consent the participation in the study.

Treatment and study plan

Skin Conductance (SC) Measurement

Other

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.

Video recording

Other

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.

Primary outcomes

  1. Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline

    Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA

    The prespecified time-points are:

    • baseline: before starting of interventions (2 minutes recording without any intervention);
    • insertion of nasopharyngeal tube;
    • insertion of laryngoscope for visualization of the vocal cords;
    • insertion of LISA catheter
    • administration of surfactant
    • removal of catheter
    • 5 minutes after removal of catheter (2 minutes recording without any intervention)
    • 1 hour (±10 minutes) after LISA (2 minutes recording without any intervention)

Secondary outcomes

  1. Median Neonatal Pain, Agitation and Sedation Scale (N-PASS) at prespecified time-points, adjusted for median N-PASS at baseline

    Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA

    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:

    • baseline: before starting of interventions
    • during insertion of laryngoscope for visualization of the vocal cords
    • administration of surfactant
    • 5 minutes after removal of catheter
    • 1 hour (±10 minutes) after LISA

  2. Absolute number of apneas

    Time frame: During LISA procedure

    Absolute number of apneas requiring non-invasive pressure ventilation or increase of peak inspiratory pressure or frequency during the LISA procedure

  3. Absolute number of desaturations

    Time frame: During LISA procedure

    Absolute number of decreasing SpO2 requiring increase of FiO2 during the LISA procedure

  4. Absolute number of bradycardia

    Time frame: During LISA procedure

    Absolute number of bradycardia (<100/min) during the LISA procedure

  5. Absolute number of arterial hypotension

    Time frame: During LISA procedure

    Absolute number of arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure

  6. Absolute number of blunt surfactant reflux

    Time frame: During LISA procedure

    Absolute number of blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure

  7. Difference in maximum peaks per second before and after apnea

    Time frame: During LISA procedure

    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

  8. Difference in median peaks per second during 20-second interval before and after apnea

    Time frame: During LISA procedure

    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

  9. Difference in maximum peaks per second before and after desaturation

    Time frame: During LISA procedure

    Difference in maximum peaks per second before and after decreasing SpO2 requiring increase of FiO2 during the LISA procedure

  10. Difference in median peaks per second during 20-second interval before and after desaturation

    Time frame: During LISA procedure

    Difference in median peaks per second during 20-second interval before and after decreasing SpO2 requiring increase of FiO2 during the LISA procedure

  11. Difference in maximum peaks per second before and after bradycardia

    Time frame: During LISA procedure

    Difference in maximum peaks per second before and after bradycardia (<100/min) during the LISA procedure

  12. Difference in median peaks per second during 20-second interval before and after bradycardia

    Time frame: During LISA procedure

    Difference in median peaks per second during 20-second interval before and after bradycardia (<100/min) during the LISA procedure

  13. Difference in maximum peaks per second before and after arterial hypotension

    Time frame: During LISA procedure

    Difference in maximum peaks per second before and after arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure

  14. Difference in median peaks per second during 20-second interval before and after arterial hypotension

    Time frame: During LISA procedure

    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

  15. Difference in maximum peaks per second before and after blunt surfactant reflux

    Time frame: During LISA procedure

    Difference in maximum peaks per second before and after blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure

  16. Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux

    Time frame: During LISA procedure

    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

  17. Difference in heart-rate between baseline and prespecified time-points as listed above.

    Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA

    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

  18. Difference in oxygen saturation between baseline and prespecified time-points as listed above.

    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 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA

  19. Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above.

    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 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA

  20. Difference of SpO2/FiO2-ratio compared to skin conductance peaks per second

    Time frame: 2 minutes before LISA, 5 minutes after removal of catheter, 60 Minutes after LISA

    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).

  21. LISA failure

    Time frame: Within 24 hours after LISA

    Incidence of LISA failure defined as intubation or repeated LISA within 24 hours

  22. Intubation <72 hours after the LISA procedure

    Time frame: Within 72 hours after LISA

    Incidence of intubation within <72 hours after the LISA procedure

  23. Air-leaks <72 hours after the LISA procedure

    Time frame: Within 72 hours after LISA

    Incidence of air-leaks within <72 hours after the LISA procedure

  24. Incidence of intraventricular hemorrhage

    Time frame: 72 hours after LISA

    Incidence of intraventricular hemorrhage at first ultrasound scan after 72 hours

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration

Acronym: PALISA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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