Pain Assessment During Less-Invasive-Surfactant-Administration

NCT06150586 | Completed

• 1 other identifier: PALISA
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  The prespecified time-points are: 1. baseline: before starting of interventions (2 minutes recording without any intervention); 2. insertion of nasopharyngeal tube; 3. insertion of laryngoscope for visualization of the vocal cords; 4. insertion of LISA catheter 5. administration of surfactant 6. removal of catheter 7. 5 minutes after removal of catheter (2 minutes recording without any intervention) 8. 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 Outcomes (24)

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

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

• Absolute number of apneas

  During LISA procedure

• Absolute number of desaturations

  During LISA procedure

• Absolute number of bradycardia

  During LISA procedure

• Absolute number of arterial hypotension

  During LISA procedure

Study Arms (1)

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; Other: Video Recording

Interventions

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.

Preterm infants with minimal gestational age of 27 weeks requiring LISA

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.

Preterm infants with minimal gestational age of 27 weeks requiring LISA

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, CH-8091, Switzerland

Location

Related Publications (9)

• 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.

  PMID: 34628413 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.

  PMID: 35124678 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.

  PMID: 18165830 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.

  PMID: 19924132 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.

  PMID: 21764228 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.

  PMID: 10952711 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.

  PMID: 18997532 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.

  PMID: 33009491 BACKGROUND

• 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.

  PMID: 41429954 RESULT

MeSH Terms

Conditions

Infant, Premature, Diseases; Respiratory Distress Syndrome; Pulmonary Atelectasis; Pain

Interventions

Weights and Measures; Videotape Recording

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Dirk Bassler, MD

  Newborn Research, Department of Neonatology, University Hospital and University of Zurich

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: December 5, 2023
• Primary Completion: June 14, 2024
• Study Completion: June 17, 2024
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)