Optimizing treatment for acute neonatal hyperammonemia
Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia
This study is testing a new way to personalize dialysis treatment for newborns with high ammonia levels to see if it can improve their health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT05754372 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on developing a user-friendly algorithm to optimize the treatment of acute neonatal hyperammonemia, a condition linked to severe neurological outcomes. The approach involves calibrating a single compartmental model based on the patient's total body water and utilizing measured ammonia time-concentration curves during hemodialysis sessions. By calculating dialyzer clearance from ammonia concentration measurements, the study aims to create tailored dialysis protocols suitable for various patient weights and clinical settings. The goal is to improve treatment efficacy and outcomes for affected neonates.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates under one year of age diagnosed with severe acute hyperammonemia due to inborn errors of metabolism.
Not a fit: Patients older than one year will not benefit from this study as they do not meet the age criteria.
Why it matters
Potential benefit: If successful, this study could significantly enhance treatment protocols for neonates suffering from acute hyperammonemia, potentially improving survival and neurological outcomes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method in optimizing treatment for this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe acute neonatal hyperammonaemia for which acute hemodialysis is indicated * inborn error of metabolism * below 1 year of age Exclusion Criteria: * older than 1 year
Where this trial is running
Ghent
- Ghent University Hospital - Department of Paediatric Nephrology — Ghent, Belgium (Recruiting)
Study contacts
- Study coordinator: Evelien Snauwaert, MD, PhD
- Email: evelien.snauwaert@uzgent.be
- Phone: 00 32 9 332 69 05
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.