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

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Urea Cycle DisordersOrganic Acidemias
Interventions
OTHER

Therapeutic Hypothermia

After obtaining written consent, patients are cooled to 33.5°C (+/- 1°C ) for 72 hours and and then rewarmed by 0.5°C per every 3 hours over 18 hours.

OTHER

Standard of Care Therapy

Patients with hyperammonemia and encephalopathy requiring renal replacement therapy due to a urea cycle disorder or organic acidemia that were treated at Children's National Medical Center over the past 10 years.

Trial Locations (3)

10027

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

20010

Children's National Medical Center, Washington D.C.

53226

Medical College Wisconsin, Milwaukee

All Listed Sponsors
collaborator

Children's National Research Institute

OTHER

collaborator

Medical College of Wisconsin

OTHER

lead

Uta Lichter-Konecki

OTHER