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NCT Number: NCT03177980

Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants

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.

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Key information

Conditions

Asphyxia Neonatorum Agnosia Asphyxia Body Temperature Changes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Hypothermia Infant, Newborn, Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries

Age range

36 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne Uniersity Hospital, Lund, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl

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

Drug

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust
  • Helsinki University Central Hospital
  • Karolinska Institutet
  • Lund University
  • The Swedish Research Council
  • University of Colorado, Denver
  • University of Tartu
  • Örebro University, Sweden

Registry information

Official study title

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

Acronym: SANNI 1

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2017
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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