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Home > "S" Clinical Trials Conditions > Stachybotrys Induced Hemorrhage in the Developing Lung  Stachybotrys Induced Hemorrhage in the Developing Lung
Stachybotrys Induced Hemorrhage in the Developing Lung
For Condition: idiopathic pulmonary hemorrhage
Status: Recruiting
Sponsor(s): National Institute of Environmental Health Sciences (NIEHS) ,
Synopsis: The majority of the workscope of this project is focussed on an infant animal model of toxigenic mold induced pulmonary hemorrhage. Clinically related studies are directed only to the description of human infants diagnosed with idiopathic pulmonary hemorrhage regarding their clinical parameters, and collecting samples of secretion, blood, and urine for analysis for fungal spores and mycotoxins. These latter analyses are being developed using the infant rat model.
Details: Over the past seven years in the Cleveland, Ohio area there have been 47 cases of unexplained pulmonary hemorrhage in young infants. Sixteen of the infants have died. A CDC case-control study found an association with water-damaged homes and the toxigenic fungus, Stachybotrys chartarum, which requires water soaked cellulose to grow. The spores of this fungus are not infectious in the lung but do contain very potent mycotoxins which appear to be particularly toxic to the rapidly developing lungs of young infants. Secondary stresses, e.g. environmental tobacco smoke, appear to be important triggers of overt hemorrhage. Concern that there may be a larger number of undetected young infants with this disorder led to the examination of all infant coroner cases, which revealed six sudden infant death syndrome cases with major amounts of pulmonary hemosiderin-laden macrophages, indicating extensive hemosiderosis existing prior to death. All of these infants had lived in the eight zip code area where all but fifteen of the patients have lived. This disorder may extend beyond Cleveland since toxigenic fungi are widespread. We are aware of a total of 138 infants with idiopathic pulmonary hemorrhage across the country over the past four years. The purpose of this proposal is to establish an infant animal model for this stachybotryomycotoxicosis which can be used to understand the developmental pathophysiology by which the fungal spores induce hemorrhage and to address practical problems faced in the clinical care of these infants and in public health prevention. The model uses tracheal instillation of toxic Stachybotrys spores in neonatal to weanling rats to initiate the pathological process, followed by stresses to trigger acute hemorrhage. Capillary fragility to transmural pressures will be assessed by morphometric analysis of electron micrographs. Markers of Stachybotrys exposure which can be applied to clinical cases are being developed and tested in the rats.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Minimum Age/Maximum Age: /12 Months
Genders: Both
Protocol Entry Criteria: infant (<12 mo old) with unexplained pulmonary hemorrhage
Total Enrollment: 50
Location and Contact Information:
Rainbow Babies and Children's Hospital, Case Western Reserve University *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Dorr Dearborn 216-844-3267
Additional Information:
Study ID Numbers: 9742-CP-001;
Study Start Date: January 1999
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011700
Other Idiopathic Pulmonary Hemorrhage Studies:
1. Stachybotrys Induced Hemorrhage in the Developing Lung
Related Studies:
Other idiopathic pulmonary hemorrhage Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Stachybotrys Induced Hemorrhage in the Developing Lung
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