Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/11/2015 |
| Start Date: | August 2007 |
| Contact: | Uta Lichter-Konecki, MD, PhD |
| Email: | ul2118@cumc.columbia.edu |
| Phone: | 212-305-6731 |
Hypothermia Treatment in Hyperammonemia and Encephalopathy
Children with neonatal onset Urea Cycle Disorders or Organic Acidemias develop
hyperammonemia (high ammonia levels) and fall into coma often causing brain damage. For
these children to be able to benefit maximally from available long-term treatment and solid
organ transplant, outcome of the neonatal onset crisis must be improved. Animal experiments
and small clinical trials have indicated that hypothermia protects the brain during
hyperammonemia. This pilot study investigates whether adjunct hypothermia therapy in
addition to standard of care treatment is feasible and safe in babies with high ammonia
levels in coma.
hyperammonemia (high ammonia levels) and fall into coma often causing brain damage. For
these children to be able to benefit maximally from available long-term treatment and solid
organ transplant, outcome of the neonatal onset crisis must be improved. Animal experiments
and small clinical trials have indicated that hypothermia protects the brain during
hyperammonemia. This pilot study investigates whether adjunct hypothermia therapy in
addition to standard of care treatment is feasible and safe in babies with high ammonia
levels in coma.
Inclusion Criteria:
- Newborns >36 wks gestation and ≥2200g birth weight without co-morbidity (see
exclusion criteria) that have clinical signs and symptoms of an Urea Cycle Disorders
or Propionic , Methylmalonic, or Isovaleric acidemia and hyperammonemia and
encephalopathy requiring renal replacement therapy.
Exclusion Criteria:
- Patients with hyperammonemia that have clinical signs and symptoms of lysinuric
protein intolerance, mitochondrial disorders, congenital lactic acidosis, and fatty
acid oxidation disorders, patients with rare and unrelated serious comorbidities and
other genetic diseases, e.g., Down syndrome, intraventricular hemorrhage in the
newborn period, traumatic brain injury, and low birth weight (<2,200 g at >36 wks
gestation).
- Infants in extremis for which no additional intensive therapy will be offered by the
attending neonatologist.
We found this trial at
3
sites
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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