Pharmacogenetics Analysis of Fentanyl Administered in Newborns

NCT05805241 | Recruiting

• 1 other identifier: RC 31/22
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Fentanyl is an opioid drug used as analgesic and anaesthetic also in Neonatal Intensive Care Units (NICU), according to the last national and international recommendations, during invasive life support strategies such as mechanical ventilation. Opioids manifest their sedative effect through activation of μ-opioid receptors, which are abundant both in the central and peripheral nervous system. Comparing fentanyl to morphine we can appreciate a much more powerful effect (75-220 major) with lower doses to obtain similar analgesic effect; these characteristics are due to the high lipophilicity of the molecule which easily crosses the blood-brain barrier (BBB). At the same time, fentanyl shows less adverse effects than morphine such as vomiting, nausea, gastrointestinal constipation, respiratory depression, dependence and tolerance. The drug is extensively metabolized by liver enzymes. In routinary clinical practice it has been observed that large interindividual differences are found in the daily dosages needed to achieve pain control. Literature evidences that pharmacodynamic variation related to genotypes in receptor signalling or pain modulators may play an important role in this variability. Many genes are related to fentanyl pharmacodynamics and pharmacokinetics. Some polymorphism in these genes are already known to correlate with toxicity or efficacy of the drug, also in the paediatric population. More polymorphisms could be involved in abnormal pharmacodynamic or pharmacokinetics of fentanyl, therefore studies are necessary to better explain the possible role of pharmacogenetics in precision medicine especially in a very specific population as newborn.

Conditions

Fentanyl; Newborn; Pharmacogenetics

Keywords

Fentanyl; Newborn; Pharmacogenetics

Outcome Measures

Primary Outcomes (2)

• Identification of already described polymorphisms

  To identify candidate polymorphisms based on the literature explaining interindividual variability in the pharmacokinetics and pharmacodynamics of fentanyl. 1 cc of blood sample will be collected

  Within 6 hours of fentanyl administration

• Identification of new polymorphisms

  To identify new polymorphisms explaining interindividual variability in the pharmacokinetics and pharmacodynamics of fentanyl. 1 cc of blood sample will be collected.

  Within 6 hours of fentanyl administration

Secondary Outcomes (1)

• To evaluate the statistical association between the polymorphisms identified and fentanyl dosage (µg/kg/hour)

  Through study completion, an average of 18 months

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All newborns admitted in NICU and mechanically ventilated (MV) who received fentanyl administration for procedural pain.

You may qualify if:

• all newborns on mechanical ventilation receiving fentanyl
• parental written informed consent for participation in the study must be obtained

You may not qualify if:

• Concurrent or previous opioid and/or midazolam administration (72 h interval required)
• Known genetic or chromosomal anomaly
• Probable rapid extubation

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1 cc of blood sample, EDTA tube for: * DNA extraction with Qiagen Symphony kit * Genotyping using Illumina Omni 2.5 + exome array

Study Officials

• Laura Travan, MD

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Central Study Contacts

Laura Travan, MD

CONTACT

+390403785505; laura.travan@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 7, 2023
• Study Start: February 7, 2023
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

IT (1)