PALISA: Pain Assessment During Less-Invasive-Surfactant-Administration

• Sponsor: University of Zurich (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06150586
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature, Diseases; Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal; Pain; Stress	Other: Skin Conductance (SC) Measurement; Other: Video Recording

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm

Intervention/Treatment

Preterm infants with minimal gestational age of 27 weeks requiring LISA LISA will be preformed according to our local standard protocol while measuring skin conductance via a specific monitor. At the same time a video is recorded for later unblinded and blinded N-PASS assessment.

Other: Skin Conductance (SC) Measurement; 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.; Other: Video Recording; 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.

Outcome Measures

Primary Outcome Measures

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

1. Median N-PASS pain score at prespecified time-points, adjusted for median N-PASS at baseline [2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA]

   The prespecified time-points 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 [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 [During LISA procedure]

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

4. Absolute number of bradycardia [During LISA procedure]

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

5. Absolute number of arterial hypotension [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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. [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. [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. [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 [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 [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 [Within 72 hours after LISA]

    Incidence of intubation within <72 hours after the LISA procedure

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

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

24. Incidence of intraventricular hemorrhage [72 hours after LISA]

    Incidence of intraventricular hemorrhage at first ultrasound scan after 72 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 48 Hours
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zürich		Switzerland	CH-8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Chair: Dirk Bassler, MD, Newborn Research, Department of Neonatology, University Hospital and University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
• Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
• Munsters J, Wallstrom L, Agren J, Norsted T, Sindelar R. Skin conductance measurements as pain assessment in newborn infants born at 22-27 weeks gestational age at different postnatal age. Early Hum Dev. 2012 Jan;88(1):21-6. doi: 10.1016/j.earlhumdev.2011.06.010. Epub 2011 Jul 20.
• Peterson J, den Boer MC, Roehr CC. To Sedate or Not to Sedate for Less Invasive Surfactant Administration: An Ethical Approach. Neonatology. 2021;118(6):639-646. doi: 10.1159/000519283. Epub 2021 Oct 8.
• Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
• Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
• Tribolet S, Hennuy N, Snyers D, Lefebvre C, Rigo V. Analgosedation before Less-Invasive Surfactant Administration: A Systematic Review. Neonatology. 2022;119(2):137-150. doi: 10.1159/000521553. Epub 2022 Feb 4.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT06150586
• Other Study ID Numbers: PALISA
• First Posted: Nov 29, 2023
• Last Update Posted: Nov 29, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Zurich: Less-Invasive-Surfactant-Administration; Skin Conductance; Neonatal Pain and Sedation Scale; Analgosedation; General stress-level
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Infant, Premature, Diseases; Syndrome

Study Results

No Results Posted as of Nov 29, 2023