FentanylNCT05805241
Pharmacogenetics Analysis of Fentanyl Administered in Newborns
An observational study of Fentanyl and Newborn, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Fentanyl, Newborn, Pharmacogenetics
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2023to 15 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: All newborns admitted in NICU and mechanically ventilated (MV) who received fentanyl administration for procedural pain.
Who may be able to join
- all newborns on mechanical ventilation receiving fentanyl
- parental written informed consent for participation in the study must be obtained
Who cannot join
- Concurrent or previous opioid and/or midazolam administration (72 h interval required)
- Known genetic or chromosomal anomaly
- Probable rapid extubation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, 34137
Laura Travan, MD, +390403785505, laura.travan@burlo.it
About this study
Official title: Pharmacogenetics Analysis in Newborn Patients on Mechanical Ventilation and Fentanyl Administration
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Within 6 hours of fentanyl administration
Secondary outcomes (1)
To evaluate the statistical association between the polymorphisms identified and fentanyl dosage (µg/kg/hour)
Association study. The univariate statistical analysis will consider the dose of fentanyl (µg/kg/hour) as a continuous dependent variable, associating it with the candidate genotypes (independent variables) by means of t-tests. The association of fentanyl dose with genotypes will also be evaluated in a multivariate model, adjusted for relevant demographic and clinical covariates, using generalized linear models.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start7 Feb 2023
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FentanylStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Travan, MD, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805241
- Sponsor's protocol ID
- RC 31/22
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics Analysis in Newborn Patients on Mechanical Ventilation and Fentanyl Administration
- ClinicalTrials.gov ID
- NCT05805241
- Acronym / sponsor ID
- RC 31/22
- Conditions
- Fentanyl, Newborn, Pharmacogenetics
- Keywords
- Fentanyl, Newborn, Pharmacogenetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All newborns admitted in NICU and mechanically ventilated (MV) who received fentanyl administration for procedural pain.
Key inclusion criteria (2 listed)
- all newborns on mechanical ventilation receiving fentanyl
- parental written informed consent for participation in the study must be obtained
Key exclusion criteria (3 listed)
- Concurrent or previous opioid and/or midazolam administration (72 h interval required)
- Known genetic or chromosomal anomaly
- Probable rapid extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of already described polymorphisms
Time frame: Within 6 hours of fentanyl administration
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
Identification of new polymorphisms
Time frame: Within 6 hours of fentanyl administration
To identify new polymorphisms explaining interindividual variability in the pharmacokinetics and pharmacodynamics of fentanyl. 1 cc of blood sample will be collected.
1 secondary outcome
To evaluate the statistical association between the polymorphisms identified and fentanyl dosage (µg/kg/hour)
Time frame: Through study completion, an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Travan, MD study director
IRCCS materno infantile Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fentanyl and Newborn, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Travan, MD (+390403785505, laura.travan@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of already described polymorphisms (time frame: Within 6 hours of fentanyl administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.