Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care
NCT ID: NCT04928651
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2018-04-06
2022-05-13
Brief Summary
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Detailed Description
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The patient will be treated according to clinical guidelines and will be included in the study if in need for clonidine according to clinical judgment (pain scores) and as decided by the responsible clinical doctor. The dosing and administration of the drug will be implemented according to an algorithm based on pain scoring results.
Apart from extra blood sampling, the bedside monitoring, investigations (electroencephalography, EEG, echocardiography, ECG, ultrasound of the brain) and follow-up (neurologic examination and magnetic resonance imaging, MRI) are the same as for all preterm infants according to local and national guidelines.
In total 100 infants will be included.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Clonidine
Preterm infants (\< gw 37+0) who are in need for analgesic or sedative medication will receive treatment with clonidine according to an algorithm based on pain and sedative scoring results
Clonidine
Clonidine will be administered to preterm infants in need of analgesia and sedation; either as the primary drug for comfort and light sedation or as an "add-on" drug to opioids according to an algorithm based on pain and sedative scoring results. Opioids are mostly given to postoperative patients. These drugs (morphine or fentanyl) will not be studied, but a baseline PK sample will be taken to correlate to the baseline aEEG.
Interventions
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Clonidine
Clonidine will be administered to preterm infants in need of analgesia and sedation; either as the primary drug for comfort and light sedation or as an "add-on" drug to opioids according to an algorithm based on pain and sedative scoring results. Opioids are mostly given to postoperative patients. These drugs (morphine or fentanyl) will not be studied, but a baseline PK sample will be taken to correlate to the baseline aEEG.
Eligibility Criteria
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Inclusion Criteria
* Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling
* Informed and written parental consent
Exclusion Criteria
* 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.
37 Weeks
ALL
No
Sponsors
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Lund University
OTHER
Karolinska Institutet
OTHER
Helsinki University Central Hospital
OTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Örebro University, Sweden
OTHER
The Swedish Research Council
OTHER_GOV
University of Tartu
OTHER
University of Colorado, Denver
OTHER
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Elisabeth Norman, MD
Role: PRINCIPAL_INVESTIGATOR
Region Skane
Locations
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Skane University Hospital
Lund, , Sweden
Marco Bartocci
Stockholm, , Sweden
Countries
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Other Identifiers
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2017-005091-26
Identifier Type: -
Identifier Source: org_study_id
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