Pain Assessment During Less-Invasive-Surfactant-Administration

The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration

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.

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.