CompletedNot Applicable

Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care

Sweden40 participantsStarted 2018-04-06

Plain-language summary

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in clonidine administered for analgesia and sedation to preterm newborn infants receiving neonatal intensive care. Phase 3 - therapeutic confirmatory study

Who can participate

Age range

37 Weeks

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 (\< gw 37+0) who are in need for analgesic or sedative medication according to clinical judgment (scoring with pain assessment scales; ALPS-Neo and Comfort-Neo) * Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling * Informed and written parental consent Exclusion Criteria: * Hemodynamic instability (same as in clinical routine). * Cardiac malformations in need for postnatal surgery. * 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

Pharmacokinetics (PK) of clonidine; S-concentration

Timeframe: Repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Pharmacokinetics (PK) of clonidine; elimination half-time

Timeframe: Data from repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Pharmacokinetics (PK) of clonidine; clearance

Timeframe: Data from repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Pharmacokinetics (PK) of clonidine; volume of distribution

Timeframe: Data from repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Neurophysiologic amplitude-integrated EEG response in relation to PK

Timeframe: From 30 minutes before start of treatment until 72 hours after start of treatment.

Trial details

NCT IDNCT04928651

SponsorRegion Skane

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-13

View on ClinicalTrials.gov More Intensive Care, Neonatal trials

Who can participate

Age range

37 Weeks

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.

What they're measuring

Pharmacokinetics (PK) of clonidine; S-concentration

Timeframe: Repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Pharmacokinetics (PK) of clonidine; elimination half-time

Timeframe: Data from repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Pharmacokinetics (PK) of clonidine; clearance

Timeframe: Data from repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Pharmacokinetics (PK) of clonidine; volume of distribution

Timeframe: Data from repeated blood samples (5 minutes after the loading dose, just before start of the clonidine infusion and at 1 hour, 24 hours, 48 hours and 72 hours after start of the infusion

Neurophysiologic amplitude-integrated EEG response in relation to PK

Timeframe: From 30 minutes before start of treatment until 72 hours after start of treatment.