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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 14, 2006 | ||||||||
| Last Updated Date | July 31, 2009 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00315263 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology | ||||||||
| Official Title ICMJE | Genomics, SNPs, and Clinical Neonatology | ||||||||
| Brief Summary | This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF). |
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| Detailed Description | This genetic predisposition study does not involve investigational drugs, devices, or treatments. Our broad goal is to identify genomic factors, which contribute to the development or exacerbation of common and critical illnesses that affect preterm and near-term infants. We seek to accomplish this goal in the following ways:
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 450 | ||||||||
| Estimated Completion Date | April 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00315263 | ||||||||
| Responsible Party | William Truog, MD, Principal Investigator, The Children's Mercy Hospitals and Clinics | ||||||||
| Study ID Numbers ICMJE | 01.3965 | ||||||||
| Study Sponsor ICMJE | Children's Mercy Hospital Kansas City | ||||||||
| Collaborators ICMJE | University of Kansas | ||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Mercy Hospital Kansas City | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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