NCT00011700

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2001

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

10 years

First QC Date

February 26, 2001

Last Update Submit

April 13, 2015

Conditions

Keywords

idiopathic pulmonary hemorrhage in infants,toxigenic mold exposure

Eligibility Criteria

Age3 Days - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rainbow Babies and Children's Hospital, Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (16)

  • Montana E, Etzel RA, Allan T, Horgan TE, Dearborn DG. Environmental risk factors associated with pediatric idiopathic pulmonary hemorrhage and hemosiderosis in a Cleveland community. Pediatrics. 1997 Jan;99(1):E5. doi: 10.1542/peds.99.1.e5.

    PMID: 9096173BACKGROUND
  • Jarvis BB, Zhou Y, Jiang J, Wang S, Sorenson WG, Hintikka EL, Nikulin M, Parikka P, Etzel RA, Dearborn DG. Toxigenic molds in water-damaged buildings: dechlorogriseofulvins from Memnoniella echinata. J Nat Prod. 1996 Jun;59(6):553-4. doi: 10.1021/np960395t.

    PMID: 8786360BACKGROUND
  • Centers for Disease Control and Prevention (CDC). Update: pulmonary hemorrhage/hemosiderosis among infants--Cleveland, Ohio, 1993-1996. MMWR Morb Mortal Wkly Rep. 1997 Jan 17;46(2):33-5.

    PMID: 9011781BACKGROUND
  • Etzel RA, Montana E, Sorenson WG, Kullman GJ, Allan TM, Dearborn DG, Olson DR, Jarvis BB, Miller JD. Acute pulmonary hemorrhage in infants associated with exposure to Stachybotrys atra and other fungi. Arch Pediatr Adolesc Med. 1998 Aug;152(8):757-62. doi: 10.1001/archpedi.152.8.757.

    PMID: 9701134BACKGROUND
  • Jarvis BB, Sorenson WG, Hintikka EL, Nikulin M, Zhou Y, Jiang J, Wang S, Hinkley S, Etzel RA, Dearborn D. Study of toxin production by isolates of Stachybotrys chartarum and Memnoniella echinata isolated during a study of pulmonary hemosiderosis in infants. Appl Environ Microbiol. 1998 Oct;64(10):3620-5. doi: 10.1128/AEM.64.10.3620-3625.1998.

    PMID: 9758776BACKGROUND
  • Yike I, Allan T, Sorenson WG, Dearborn DG. Highly sensitive protein translation assay for trichothecene toxicity in airborne particulates: comparison with cytotoxicity assays. Appl Environ Microbiol. 1999 Jan;65(1):88-94. doi: 10.1128/AEM.65.1.88-94.1999.

    PMID: 9872764BACKGROUND
  • Dearborn DG, Yike I, Sorenson WG, Miller MJ, Etzel RA. Overview of investigations into pulmonary hemorrhage among infants in Cleveland, Ohio. Environ Health Perspect. 1999 Jun;107 Suppl 3(Suppl 3):495-9. doi: 10.1289/ehp.99107s3495.

    PMID: 10346998BACKGROUND
  • Vesper SJ, Dearborn DG, Yike I, Sorenson WG, Haugland RA. Hemolysis, toxicity, and randomly amplified polymorphic DNA analysis of Stachybotrys chartarum strains. Appl Environ Microbiol. 1999 Jul;65(7):3175-81. doi: 10.1128/AEM.65.7.3175-3181.1999.

    PMID: 10388719BACKGROUND
  • 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.

    BACKGROUND
  • Tripi PA, Modlin S, Sorenson WG, Dearborn DG. Acute pulmonary haemorrhage in an infant during induction of general anaesthesia. Paediatr Anaesth. 2000;10(1):92-4. doi: 10.1046/j.1460-9592.2000.00452.x.

    PMID: 10632917BACKGROUND
  • Vesper S, Dearborn DG, Yike I, Allan T, Sobolewski J, Hinkley SF, Jarvis BB, Haugland RA. Evaluation of Stachybotrys chartarum in the house of an infant with pulmonary hemorrhage: quantitative assessment before, during, and after remediation. J Urban Health. 2000 Mar;77(1):68-85. doi: 10.1007/BF02350963.

    PMID: 10741843BACKGROUND
  • Vesper SJ, Dearborn DG, Elidemir O, Haugland RA. Quantification of siderophore and hemolysin from Stachybotrys chartarum strains, including a strain isolated from the lung of a child with pulmonary hemorrhage and hemosiderosis. Appl Environ Microbiol. 2000 Jun;66(6):2678-81. doi: 10.1128/AEM.66.6.2678-2681.2000.

    PMID: 10831457BACKGROUND
  • Vesper SJ, Magnuson ML, Dearborn DG, Yike I, Haugland RA. Initial characterization of the hemolysin stachylysin from Stachybotrys chartarum. Infect Immun. 2001 Feb;69(2):912-6. doi: 10.1128/IAI.69.2.912-916.2001.

    PMID: 11159985BACKGROUND
  • Dearborn DG. Pulmonary hemorrhage in infants and children. Curr Opin Pediatr. 1997 Jun;9(3):219-24. doi: 10.1097/00008480-199706000-00005.

    PMID: 9229159BACKGROUND
  • 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.

    BACKGROUND
  • Dearborn DG, Smith PG, Dahms BB, Allan TM, Sorenson WG, Montana E, Etzel RA. Clinical profile of 30 infants with acute pulmonary hemorrhage in Cleveland. Pediatrics. 2002 Sep;110(3):627-37. doi: 10.1542/peds.110.3.627.

Study Officials

  • Dorr G Dearborn, MD, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

February 26, 2001

First Posted

February 28, 2001

Study Start

January 1, 1999

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations