Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care (NCT06482775) | Clinical Trial Compass
WithdrawnNot Applicable
Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care
Stopped: Problems with the study costs after Covid-19
Sweden0Started 2021-06-01
Plain-language summary
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Phase III - therapeutic confirmatory study.
Who can participate
Age range
27 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:
* Newborn infants: - born 34+0 gw with a need for dexmedetomidine for analgesic and/or sedative treatment after postnatal surgical correction of congenital malformations and who will be cared for in the PICU (postoperative intensive care unit) and in a some few cases in the NICU (neonatal intensive care unit), or
* with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment and cared for in the NICU.
* Existing arterial or venous cannulas/catheters for repeated nontraumatic blood sampling
* Informed and written parental consent obtained before study start.
Exclusion Criteria:
* Infant older than age corresponding to gw 46+0
* Previous treatment with the dexmedetomidine within 72 hours (only for postoperative infants).
* Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia.
* Ongoing renal replacement treatment
* Any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.
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
1
Pharmacokinetics (PK) of dexmedetomidine
Timeframe: Repeated blood samples (5 minutes after the loading dose until 12 hours after stop of infusion)
2
Neurophysiologic response; global brain network function in relation to PK
Timeframe: Baseline until 12 hours after stop of infusion