The Early History of Universal Screening for Metabolic Disorders
Recruitment status was Active, not recruiting
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Purpose
We are doing this study to learn more about the early history of universal screening for metabolic disorders such as PKU and galactosemia. In particular, we are interested in learning from our past experience to inform our current plans to expand universal newborn screening. Following standard historical research methodology, we will begin with a review of the historical scholarship on PKU and galactosemia, including more general works on mental retardation, genetics, public health screening, and metabolic disorders. We will also obtain scientific publications and archival sources on the early screening and treatment of these disorders. Lastly, we will conduct oral history interviews with key participants in teh early screening and treatment of PKU and galactosemia.
| Condition |
|---|
|
Phenylketonuria Galactosemia Inborn Errors of Metabolism |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Retrospective |
| Official Title: | The Early History of Universal Screening for Metabolic Disorders |
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | July 2007 |
Universal neonatal screening programs for metabolic disorders constitute a triumph of medicine and public policy in the US over the last 50 years. State programs to identify and treat disorders such as and galactosemia have saved thousands of lives and prevented serious morbidity such hypothyroidism, phenylketonuria (PKU), as mental retardation . Advances in science and technology, including the Human Genome Project, offer the opportunity to expand universal newborn screening programs to include many new conditions. Although the benefits of such screening programs appear to outweigh their costs, some critics have pointed to historical examples that should make us wary of expanding universal newborn screening. For example, ethicist Norm Fost has stated that early screening programs falsely identified hundreds of children as having PKU or galactosemia, and that inappropriate treatment of these children led to death or severe neurodevelopmental impairment . As our nation weighs the risks and benefits of expanding newborn screening to a variety of metabolic and genetic conditions, it is critical to revisit the early years of universal screening programs. Did the extension of screening from at-risk populations to all newborns lead to substantial morbidity and mortality? If so, what can we learn from our past experience to inform our current plans to expand universal newborn screening?
We propose to examine the early history of universal screening for PKU and galactosemia in the US. Following standard historical research methodology, we will begin with a review of the historical scholarship on PKU and galactosemia, including more general works on mental retardation, genetics, public health screening, and metabolic disorders. We will also identify and obtain scientific publications and archival sources that document the early screening and treatment of these disorders. Lastly, we will conduct oral history interviews with key participants in the history of early screening and treatment of PKU and galactosemia. Oral history is a critical component of this project, providing information not available in any other format. Through oral history interviews, we hope to identify critical events, key people, and important collateral influencing issues.
The second phase of historical methods requires the scholar to identify key themes based on the historical record, then present preliminary findings to groups of scholars from a variety of disciplines. This academic exchange leads the PI to new resources and to refined key themes. The final phase of historical scholarship is preparation of written conclusions. As a result of this project, a historical article will be written for a peer-reviewed journal accessible to clinicians, researchers, and policy experts who are considering how best to expand universal metabolic screening.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- participants in the history of early screening and treatment of PKU and galactosemia
Exclusion Criteria:
- those who decline to be interviewed
Contacts and Locations| United States, Florida | |
| University of Miami Mailman Center for Child Development | |
| Miami, Florida, United States, 33101 | |
| Principal Investigator: | Jeffrey P Brosco, MD, PhD | University of Miami |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00309400 History of Changes |
| Other Study ID Numbers: | 2005-7601 |
| Study First Received: | March 30, 2006 |
| Last Updated: | April 19, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Miami:
|
History Phenylketonuria Galactosemia Screening Treatment |
Additional relevant MeSH terms:
|
Galactosemias Metabolic Diseases Metabolism, Inborn Errors Phenylketonurias Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Genetic Diseases, Inborn Carbohydrate Metabolism, Inborn Errors Amino Acid Metabolism, Inborn Errors |
ClinicalTrials.gov processed this record on May 21, 2013