CompletedNot Applicable

Pain Assessment During Less-Invasive-Surfactant-Administration

Switzerland21 participantsStarted 2023-12-05

Plain-language 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.

Who can participate

Age range

48 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT06150586

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-14

View on ClinicalTrials.gov More Infant, Premature, Diseases trials