Optimizing treatment for acute neonatal hyperammonemia
Official title: Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia
Run by University Hospital, Ghent · NCT05754372 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 1 Year |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Status | Recruiting |
| Started | January 15, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | April 15, 2024 |
| Trial ID | NCT05754372 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients older than one year will not benefit from this study as they do not meet the age criteria.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.