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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline | The prespecified time-points are:
| 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Bassler, MD | Newborn Research, Department of Neonatology, University Hospital and University of Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | CH-8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34628413 | Background | 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. | |
| 35124678 | Background | 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. |
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D012128 | Respiratory Distress Syndrome |
| D001261 | Pulmonary Atelectasis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
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|
| 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. |
|
| 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 | During LISA procedure |
| Absolute number of desaturations | Absolute number of decreasing SpO2 requiring increase of FiO2 during the LISA procedure | During LISA procedure |
| Absolute number of bradycardia | Absolute number of bradycardia (<100/min) during the LISA procedure | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). | 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 | Within 24 hours after LISA |
| Intubation <72 hours after the LISA procedure | Incidence of intubation within <72 hours after the LISA procedure | Within 72 hours after LISA |
| Air-leaks <72 hours after the LISA procedure | Incidence of air-leaks within <72 hours after the LISA procedure | Within 72 hours after LISA |
| Incidence of intraventricular hemorrhage | Incidence of intraventricular hemorrhage at first ultrasound scan after 72 hours | 72 hours after LISA |
| 18165830 | Background | 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. |
| 19924132 | Background | 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. |
| 21764228 | Background | 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. |
| 10952711 | Background | 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. |
| 18997532 | Background | 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. |
| 33009491 | Background | 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. |
| 41429954 | Result | Dirler C, Boos V, Bassler D, Benke-Bruderer S, Held U, Ruegger CM, Muehlbacher T. Pain Assessment During Less Invasive Surfactant Administration Using Skin Conductance: A Prospective Cohort Study. Pediatr Res. 2025 Dec 22. doi: 10.1038/s41390-025-04703-9. Online ahead of print. |
| D012120 | Respiration Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |