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Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315263
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : August 26, 2011
University of Kansas
Information provided by:
Children's Mercy Hospital Kansas City

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).

Condition or disease
Lung Disease Brain Injury Necrotizing Enterocolitis Respiratory Failure

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:

  • First: to test candidate gene DNA variations and link already identified single nucleotide polymorphisms (SNPs) producing functional alterations to the risk of clinically important disorders.
  • Second: to utilize a whole-genomic approach to identify SNPs not previously linked to the risk of development or progression of neonatal disorders.

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genomics, SNPs, and Clinical Neonatology
Study Start Date : April 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Whole Blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive Care Nursery

Inclusion Criteria:

  • Less than 34 weeks gestation and less than 1500 g at birth
  • Greater than or equal to 36 weeks gestation and either with hypoxic respiratory failure or with mild respiratory distress never requiring assisted ventilation

Exclusion Criteria:

  • Life threatening anomalies of any organ system (e.g., cardiac, thoracic, lethal, or non-lethal chromosomal abnormalities)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315263

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United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Truman Medical Center
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of Kansas
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Principal Investigator: William E Truog, MD Children's Mercy Hospital Kansas City

Additional Information:
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Responsible Party: William Truog, MD, Principal Investigator, The Children's Mercy Hospitals and Clinics Identifier: NCT00315263    
Other Study ID Numbers: 01.3965
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011
Keywords provided by Children's Mercy Hospital Kansas City:
Chronic Lung Disease
Periventricular Brain Injury
Hypoxic Respiratory Failure
Additional relevant MeSH terms:
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Enterocolitis, Necrotizing
Lung Diseases
Respiratory Insufficiency
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Respiratory Tract Diseases
Respiration Disorders
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases