Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia

NCT ID: NCT05754372

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-15

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. A user-friendly and widely applicable algorithm - based on kinetics - to tailor the treatment of acute neonatal hyperammonemia. A single compartmental model was calibrated assuming a distribution volume equal to the patient's total body water (V), as calculated using Wells' formula, and dialyzer clearance as derived from the measured ammonia time-concentration curves during 11 dialysis sessions in four patients (3.2 +/- 0.4 kg). Based on these kinetic simulations, dialysis protocols could be derived for clinical use with different body weights, start concentrations, dialysis machines/dialyzers and dialysis settings (e.g., blood flow QB). By a single measurement of ammonia concentration at the dialyzer inlet and outlet, dialyzer clearance (K) can be calculated as K = QB\[(Cinlet - Coutlet)/Cinlet\]. The time (T) needed to decrease the ammonia concentration from a predialysis start concentration Cstart to a desired target concentration Ctarget is then equal to T = (-V/K)LN(Ctarget/Cstart). By implementing these formulae in a simple spreadsheet, medical staff can draw an institution-specific flowchart for patient-tailored treatment of hyperammonemia.

The aim of this study is to validate these formula with a prospective study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperammonemic Encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hyperammonaemia

user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia

Intervention Type DIAGNOSTIC_TEST

user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia, based on kinetic modelling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia

user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia, based on kinetic modelling

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ghent University Hospital - Department of Paediatric Nephrology

Ghent, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Evelien Snauwaert, MD, PhD

Role: CONTACT

00 32 9 332 69 05

Sunny Eloot, PhD

Role: CONTACT

00 32 9 332 10 25

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Evelien Snauwaert, MD PhD

Role: primary

0032 9 332 5271

Sunny Eloot, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BC-10637

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fluid Balance Study in Sick Neonates
NCT00962754 COMPLETED PHASE4
Early Sodium Intake in Preterm Newborns
NCT04035564 COMPLETED PHASE4