Clinical trial NCT06150586: Pain Assessment During Less-Invasive-Surfactant-Administration
Official title: The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature, Diseases
Respiratory Distress Syndrome
Surfactant Deficiency Syndrome Neonatal
Pain
Stress
Keywords: Less-Invasive-Surfactant-Administration
Skin Conductance
Neonatal Pain and Sedation Scale
Analgosedation
General stress-level
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 21
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All preterm infants with ≥27 0/7 weeks of gestation at birth who meet the inclusion criteria and who do not fulfill the exclusion criteria

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline
timeFrame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Secondary outcomes:
measure: Median Neonatal Pain, Agitation and Sedation Scale (N-PASS) at prespecified time-points, adjusted for median N-PASS at baseline
timeFrame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
measure: Absolute number of apneas
timeFrame: During LISA procedure
measure: Absolute number of desaturations
timeFrame: During LISA procedure
measure: Absolute number of bradycardia
timeFrame: During LISA procedure
measure: Absolute number of arterial hypotension
timeFrame: During LISA procedure
measure: Absolute number of blunt surfactant reflux
timeFrame: During LISA procedure
measure: Difference in maximum peaks per second before and after apnea
timeFrame: During LISA procedure
measure: Difference in median peaks per second during 20-second interval before and after apnea
timeFrame: During LISA procedure
measure: Difference in maximum peaks per second before and after desaturation
timeFrame: During LISA procedure
measure: Difference in median peaks per second during 20-second interval before and after desaturation
timeFrame: During LISA procedure
measure: Difference in maximum peaks per second before and after bradycardia
timeFrame: During LISA procedure
measure: Difference in median peaks per second during 20-second interval before and after bradycardia
timeFrame: During LISA procedure
measure: Difference in maximum peaks per second before and after arterial hypotension
timeFrame: During LISA procedure
measure: Difference in median peaks per second during 20-second interval before and after arterial hypotension
timeFrame: During LISA procedure
measure: Difference in maximum peaks per second before and after blunt surfactant reflux
timeFrame: During LISA procedure
measure: Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux
timeFrame: During LISA procedure
measure: Difference in heart-rate between baseline and prespecified time-points as listed above.
timeFrame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
measure: Difference in oxygen saturation between baseline and prespecified time-points as listed above.
timeFrame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
measure: Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above.
timeFrame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
measure: Difference of SpO2/FiO2-ratio compared to skin conductance peaks per second
timeFrame: 2 minutes before LISA, 5 minutes after removal of catheter, 60 Minutes after LISA
measure: LISA failure
timeFrame: Within 24 hours after LISA
measure: Intubation <72 hours after the LISA procedure
timeFrame: Within 72 hours after LISA
measure: Air-leaks <72 hours after the LISA procedure
timeFrame: Within 72 hours after LISA
measure: Incidence of intraventricular hemorrhage
timeFrame: 72 hours after LISA
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Newborn Research, Department of Neonatology, University Hospital and University of Zurich
name: Dirk Bassler, MD
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.
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.
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.
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.
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.