Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01624311 · ClinicalTrials.gov registry record · Phase 2

Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants

A Phase 2 study of Urea Cycle Disorders and Organic Acidemias, sponsored by Uta Lichter-Konecki.

Completed
Registry status
Phase 2
Development phase
5
Enrollment target
3
Study locations

NCT01624311 is a Phase 2 study of Urea Cycle Disorders and Organic Acidemias that has completed, run by Uta Lichter-Konecki. The registered enrollment target is 5 participants, below the 396-participant average among 4 other Urea Cycle Disorders trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01624311, a Phase 2 study of Urea Cycle Disorders and Organic Acidemias, has completed, sponsored by Uta Lichter-Konecki.

COMPLETED
Registry status
Phase 2
Development phase
5 participants
Enrollment target
3
Study locations

Study Summary

This is a pilot study which will test the safety and feasibility of hypothermia treatment as adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates versus conventional treatment (dialysis, nutritional therapy, and ammonia scavenging drugs) only. The endpoint of the pilot study will be reached when either 24 patients have been enrolled and no serious adverse events were observed, when no patient has been enrolled in 5 years, or when serious adverse events occur which are clearly linked to the use of hypothermia. These would be serious complications not seen in patients on conventional therapy (dialysis , nutritional therapy, ammonia scavenging drugs) for HAE.

Conditions Studied

Urea Cycle Disorders Organic Acidemias

Interventions

  • OTHER Therapeutic Hypothermia
  • OTHER Standard of Care Therapy

Study Locations (3)

District of Columbia

  • Children's National Medical Center - Washington D.C.

New York

  • Columbia University, Morgan Stanley Children's Hospital - New York

Wisconsin

  • Medical College Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2007-08
Est. Completion 2015-05
Phase Phase 2

Sponsor

Uta Lichter-Konecki

1 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01624311

The ClinicalTrials.gov registry entry for NCT01624311 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 396-participant average among 4 other Urea Cycle Disorders trials with a reported enrollment target (99% lower). The listed sponsor is Uta Lichter-Konecki, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Urea Cycle Disorders appearing as the primary indexed condition, and to 2 interventions - of which Therapeutic Hypothermia is the first listed.

NCT01624311 reports 3 study locations spanning 3 distinct geographic areas - top geographies include District of Columbia, New York, Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01624311 about?

NCT01624311 is a clinical study titled "Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants". This is a pilot study which will test the safety and feasibility of hypothermia treatment as adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates versus conventional treatment (dialysis, nutritional therapy, and ammonia scavenging drugs) only. The endpoint of ...

What is the current status of trial NCT01624311?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2007-08. Estimated completion is 2015-05.

What conditions does trial NCT01624311 study?

This clinical trial studies the following conditions: Urea Cycle Disorders, Organic Acidemias.

What interventions are being tested in trial NCT01624311?

The interventions under investigation include: Therapeutic Hypothermia (OTHER), Standard of Care Therapy (OTHER).

Who is sponsoring clinical trial NCT01624311?

This trial is sponsored by Uta Lichter-Konecki, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01624311 being conducted?

This trial has 3 study locations across District of Columbia, New York, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Urea Cycle Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Urea Cycle Disorders

All registered trials for this condition

Organic Acidemias

All registered trials for this condition

District of Columbia

All trials with a study site in District of Columbia

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.