Pain Clinical Trial
— PALISAOfficial title:
The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration
| NCT number | NCT06150586 |
| Other study ID # | PALISA |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 5, 2023 |
| Est. completion date | June 17, 2024 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | June 17, 2024 |
| Est. primary completion date | June 14, 2024 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 48 Hours |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
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. — View Citation
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. — View Citation
Morgan ME, Kukora S, Nemshak M, Shuman CJ. Neonatal Pain, Agitation, and Sedation Scale's use, reliability, and validity: a systematic review. J Perinatol. 2020 Dec;40(12):1753-1763. doi: 10.1038/s41372-020-00840-7. Epub 2020 Oct 2. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline | 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) |
2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA | |
| Secondary | 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: 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 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA | |
| Secondary | 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 | During LISA procedure | |
| Secondary | Absolute number of desaturations | Absolute number of decreasing SpO2 requiring increase of FiO2 during the LISA procedure | During LISA procedure | |
| Secondary | Absolute number of bradycardia | Absolute number of bradycardia (<100/min) during the LISA procedure | During LISA procedure | |
| Secondary | Absolute number of arterial hypotension | Absolute number of arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure | During LISA procedure | |
| Secondary | Absolute number of blunt surfactant reflux | Absolute number of blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | During LISA procedure | |
| Secondary | 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 | 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA | |
| Secondary | 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 | 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA | |
| Secondary | 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 | 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA | |
| Secondary | 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). | 2 minutes before LISA, 5 minutes after removal of catheter, 60 Minutes after LISA | |
| Secondary | LISA failure | Incidence of LISA failure defined as intubation or repeated LISA within 24 hours | Within 24 hours after LISA | |
| Secondary | Intubation <72 hours after the LISA procedure | Incidence of intubation within <72 hours after the LISA procedure | Within 72 hours after LISA | |
| Secondary | Air-leaks <72 hours after the LISA procedure | Incidence of air-leaks within <72 hours after the LISA procedure | Within 72 hours after LISA | |
| Secondary | Incidence of intraventricular hemorrhage | Incidence of intraventricular hemorrhage at first ultrasound scan after 72 hours | 72 hours after LISA |
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