- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177980
Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants (SANNI 1)
Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants - a Prospective Pharmacokinetic/Pharmacodynamic/Pharmacogenetic Observational Study. Cohort 1 in The SANNI Project.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients that are admitted to the study neonatal intensive care units (NICUs) for hypothermic treatment due to perinatal asphyxia are potential study patients, and their parents will be asked for consent.
The patient will be treated according to clinical guidelines and will be included in the study if in need for fentanyl and clonidine according to clinical judgment (HIE and pain scores) and as decided by the responsible clinical doctor. The dosing and administration of the drugs 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 magnetic resonance imaging, (MRI)) and follow-up (neurologic examination) are the same as for all infants receiving hypothermia according to national and international guidelines. A brief standardised pain stimulation will be performed as part of the pain and stress assessment.
In total 50 infants will be included.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lund, Sweden, 221 85
- Skåne Uniersity Hospital
-
Stockholm, Sweden, 171 76
- Karolinska University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Term infants (≥ gw 36+0) who, according to national guidelines (6), will receive hypothermic treatment following perinatal asphyxia, and are in need for analgesic or sedative medication according to clinical judgment based on Thomsons score and ALPS-Neo.
- Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling
- Informed and written parental consent.
Exclusion Criteria:
- Atrioventricular (AV)- block I-III or heart rate < 70 .
- Serious coronary heart disease with need for postnatal surgery
- Mean arterial blood pressure <35 mmHg despite adequate treatment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fentanyl
All infants in need of analgesia according to an algorithm based on pain assessment results will receive fentanyl as the first analgesic drug.
|
The dosing and administration of fentanyl will serve as the first drug intervention in infants in need of analgesia according to an algorithm based on pain scoring results.
|
Fentanyl and Clonidine
Infants in need of further analgesia according to an algorithm based on pain assessment results will receive fentanyl and clonidine as the analgesic drugs.
|
In infants in need of further analgesia clonidine will be administered as an add on drug according to an algorithm based on pain scoring results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) of fentanyl and clonidine
Time Frame: Repeated blood samples over a total of 4 - 7 days]
|
Analysed with NONMEM (Non-linear Mixed Effect Modelling) populationbased PK statistics
|
Repeated blood samples over a total of 4 - 7 days]
|
Neurophysiologic response; by single cortical events and their dynamics in relation to PK
Time Frame: From admission to the department until 4- 72 h after reaching normothermia.]
|
Analyse of single cortical events and their dynamics based on burst detection and measuring features of individual bursts as well as their mass statistical behaviour over time.
|
From admission to the department until 4- 72 h after reaching normothermia.]
|
Neurophysiologic response; longer term brain function in relation to PK
Time Frame: From admission to the department until 4- 72 h after reaching normothermia
|
Assessment of longer term brain function using measures of long range correlation and brain activity cycling.
|
From admission to the department until 4- 72 h after reaching normothermia
|
Neurophysiologic response; global brain network function in relation to PK
Time Frame: From admission to the department until 4- 72 h after reaching normothermia
|
Assessment of global brain network function will be based on Activation Synchrony Index.
|
From admission to the department until 4- 72 h after reaching normothermia
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in/association between physiological parameters (heart rate, blood pressure, peripheral oxygen saturation and NIRS (near-infrared reflectance spectroscopy near-infrared spectroscopy) parameters) in relation to PK parameters
Time Frame: From admission to the department until 4- 72 h after reaching normothermia.
|
From admission to the department until 4- 72 h after reaching normothermia.
|
Change in pain responses as measured by pain assessment score for continuous pain/stress (ALPS-Neo and Comfort Neo) in relation to PK
Time Frame: From admission to the department until 4- 72 h after reaching normothermia.
|
From admission to the department until 4- 72 h after reaching normothermia.
|
Procedural pain response at a short standardized pain stimulation; as assessed with change in galvanic skin response, change in serum-cortisol and scored by a procedural pain assessment scale (PIPP-R) in relation to PK.
Time Frame: Once during stable treatment with hypothermia and 6 hours of unchanged medication
|
Once during stable treatment with hypothermia and 6 hours of unchanged medication
|
Pharmacogenetic profile in relation to PK and PD results; how PK/PD phenotypes depend on pharmacogenetic (PG) profiles.
Time Frame: One blood sample during study
|
One blood sample during study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elisabeth Norman, MD, Region Skane and Lunds University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Wounds and Injuries
- Infant, Newborn, Diseases
- Death
- Body Temperature Changes
- Hypothermia
- Asphyxia
- Asphyxia Neonatorum
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Sympatholytics
- Fentanyl
- Clonidine
Other Study ID Numbers
- 2015-002470-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asphyxia Neonatorum
-
Sharp HealthCareSharp Mary Birch Hospital for Women & NewbornsActive, not recruitingBirth Asphyxia With Neurologic InvolvementUnited States, Canada
-
University of Health Sciences LahoreNot yet recruiting
-
Sharp HealthCareSharp Mary Birch Hospital for Women & NewbornsCompleted
-
Universidad Peruana Cayetano HerediaGrand Challenges Canada; Instituto Nacional de Salud del Niño. Lima, PeruCompleted
-
Pia WintermarkWalimu; Kawempe National Referral Hospital; Saint Francis Memorial HospitalRecruiting
-
Sheri Kashmir Institute of Medical SciencesCompleted
-
Tanta UniversityCompleted
-
Massachusetts General HospitalUnited States Agency for International Development (USAID); Grand Challenges...Active, not recruitingPerinatal Asphyxia | Asphyxia Neonatorum | Birth AsphyxiaUnited States
-
Massachusetts General HospitalCompletedPerinatal Asphyxia | Asphyxia Neonatorum | Birth Asphyxia
-
Sharp HealthCareEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
Clinical Trials on Fentanyl
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)CompletedPeer Review, ResearchUnited States
-
Alexza Pharmaceuticals, Inc.Completed
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
University of Texas Southwestern Medical CenterCompletedPregnancyUnited States
-
Janssen Research & Development, LLCCompleted
-
Samuel Lunenfeld Research Institute, Mount Sinai...Terminated
-
University of PatrasUnknownStillborn Caesarean SectionGreece
-
Johns Hopkins UniversityCompletedIntracranial SurgeryUnited States
-
Janssen Korea, Ltd., KoreaCompletedChronic PainKorea, Republic of