Pain Assessment During Less-Invasive-Surfactant-Administration (PALISA)

University of Zurich (UZH)

Status: Completed

Conditions: Infant, Premature, Diseases; Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal; Pain; Stress

Treatments: Other: Video Recording; Other: Skin Conductance (SC) Measurement

Study type: Observational

Funder types: Other

Identifiers

NCT06150586

PALISA

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

Preterm infants with minimal gestational age of 27 weeks requiring LISA

Description:

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.

Treatment:

Other: Skin Conductance (SC) Measurement

Other: Video Recording