Analyzing how genetics affect fentanyl use in newborns
Pharmacogenetics Analysis in Newborn Patients on Mechanical Ventilation and Fentanyl Administration
This study is testing how genetic differences in newborns affect their response to fentanyl used for pain relief while they are on a ventilator in the NICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT05805241 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on newborns in Neonatal Intensive Care Units (NICU) who are receiving fentanyl for pain management during mechanical ventilation. It aims to investigate the pharmacogenetic factors that may influence the effectiveness and safety of fentanyl in this vulnerable population. By examining genetic variations, the study seeks to understand the interindividual differences in response to fentanyl, which could lead to more personalized pain management strategies for newborns. Parental consent is required for participation, and specific inclusion and exclusion criteria are in place to ensure the safety of participants.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns on mechanical ventilation who are receiving fentanyl for analgesia.
Not a fit: Patients who have received other opioids or midazolam within the last 72 hours or have known genetic anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management protocols for newborns, minimizing adverse effects and enhancing recovery.
How similar studies have performed: While pharmacogenetic studies in adults have shown promise, this specific approach in newborns is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. all newborns on mechanical ventilation receiving fentanyl 2. parental written informed consent for participation in the study must be obtained Exclusion Criteria: 1. Concurrent or previous opioid and/or midazolam administration (72 h interval required) 2. Known genetic or chromosomal anomaly 3. Probable rapid extubation
Where this trial is running
Trieste
- IRCCS Burlo Garofolo — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Laura Travan, MD
- Email: laura.travan@burlo.trieste.it
- Phone: +390403785505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.