Status:

COMPLETED

Pain Assessment During Less-Invasive-Surfactant-Administration

Lead Sponsor:

University of Zurich

Conditions:

Infant, Premature, Diseases

Respiratory Distress Syndrome

Eligibility:

All Genders

Up to 48 years

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-Surfa...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 5 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 17 2024

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT06150586

Start Date

December 5 2023

End Date

June 17 2024

Last Update

July 3 2024

Active Locations (1)

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1

University Hospital Zurich

Zurich, Switzerland, CH-8091