Stachybotrys Induced Hemorrhage in the Developing Lung

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by National Institute of Environmental Health Sciences (NIEHS).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00011700
First received: February 26, 2001
Last updated: December 1, 2006
Last verified: February 2006
  Purpose

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.


Condition
Idiopathic Pulmonary Hemorrhage

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 50
Study Start Date: January 1999
Estimated Study Completion Date: February 2010
Detailed Description:

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

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion: infant (<12 mo old) with unexplained pulmonary hemorrhage, discharged home from newborn nursery Exclusion: hemorrhage occurred in hospital prior to going home prior to discharge from newborn nursery

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00011700

Locations
United States, Ohio
Rainbow Babies and Children's Hospital, Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Dorr G Dearborn, MD,PhD    216-844-3267    dxd9@po.cwru.edu   
Principal Investigator: Dorr G Dearborn, MD,PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Dorr G Dearborn, MD, PhD Case Western Reserve University
  More Information

Additional Information:
Publications:
Etzel, R.A., and Dearborn, D.G. Pulmonary hemorrhage among infants with exposure to toxigenic molds: An update. In: Bioaerosols, Fungi, and Mycotoxins:Health effect, Assessment, Prevention and Control, Ed. E. Johanning, Boyd Printing Co., Inc., Albany, NY, 1999, pp 70-83.
Dearborn DG. Pulmonary Hemosiderosis (pulmonary hemorrhage), in Nelson's Textbook of Pediatrics, 16th edition. Editors: R Behrman, R Kleigman, H Jenson, p 1295-1297, 2000.

ClinicalTrials.gov Identifier: NCT00011700     History of Changes
Other Study ID Numbers: 9742-CP-001
Study First Received: February 26, 2001
Last Updated: December 1, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
idiopathic pulmonary hemorrhage in infants,
toxigenic mold exposure

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014