Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants (SANNI 1)

June 8, 2021 updated by: Region Skane

Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants - a Prospective Pharmacokinetic/Pharmacodynamic/Pharmacogenetic Observational Study. Cohort 1 in The SANNI Project.

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in the NICU.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lund, Sweden, 221 85
        • Skåne Uniersity Hospital
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Term asphyxiated infants admitted to the NICU for hypothermic treatment according to national and international guidelines and in need for analgesia according to pain assessment scales.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 24, 2017

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

April 1, 2021

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (ACTUAL)

June 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

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.

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