Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Prete… (NCT00758511) | Clinical Trial Compass
CompletedEarly Phase 1
Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit
Switzerland71 participantsStarted 2009-01
Plain-language summary
Switzerland is having one of the highest premature rates in Europa and most of the preterm neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive care units are either "off label used" or "non-licensed" used. As an alternative approach non-pharmacological interventions for pain prevention and relief are increasingly being recommended for the prevention and treatment of mild and moderate pain in this population.
This multicenter pilot study will use a randomized three group,repeated measures design.
The primary aims of this study of premature neonates are to:
1.) Estimate effect sizes for the impact of the proposed interventions(facilitated tucking alone, sucrose alone and sucrose in combination with tucking)on pain reactivity.
2.) Examine the impact of gestational age on the estimates of efficacy 3.) Examine the impact of the numbers of painful procedures the infant experiences and the concurrent use of analgesic medications on the estimates of efficacy
Who can participate
Age range
1 Day – 15 Days
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:
* must be born between 24 0/7 and 32 0/7 weeks of gestation
* must be hospitalized in the NICU
* it must be anticipated that they will need at least 5 routine heel sticks
* their parents give informed consent
Exclusion Criteria:
had a high-grade intraventricular hemorrhaging (grade III and IV);
* have a severe, life-threatening malformations;
* are suffering from any condition involving partial or total loss of sensitivity
* had a pHa \< 7.00;
* had surgery for any reason; or
* have a congenital malformation affecting brain circulation or the cardiovascular system.
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.