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Pain Assessment During Less-Invasive-Surfactant-Administration

NCT06150586 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2026-02-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Dirk Bassler, MD · Newborn Research, Department of Neonatology, University Hospital and University of Zurich

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2024-06-14
Completion
2024-06-17

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06150586 on ClinicalTrials.gov