Clinical trial Recruiting at 1 site Observational Ages Any age to 1 Year

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 typeObservational
AgesAny age to 1 Year
SexAll
Enrollment10 (estimated)
SponsorUniversity Hospital, Ghent
Academic / other
Locations1 site (Ghent)
StatusRecruiting
StartedJanuary 15, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedApril 15, 2024
Trial IDNCT05754372 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.