Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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.
 
ClinicalTrials.gov Identifier: NCT00315263
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : August 26, 2011
Sponsor:
Collaborator:
University of Kansas
Information provided by:
Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date April 14, 2006
First Posted Date April 18, 2006
Last Update Posted Date August 26, 2011
Study Start Date April 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00315263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology
Official Title 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).
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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood
Sampling Method Non-Probability Sample
Study Population Intensive Care Nursery
Condition
  • Lung Disease
  • Brain Injury
  • Necrotizing Enterocolitis
  • Respiratory Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 25, 2011)
63
Original Enrollment
 (submitted: April 14, 2006)
890
Actual Study Completion Date July 2011
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00315263
Other Study ID Numbers 01.3965
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party William Truog, MD, Principal Investigator, The Children's Mercy Hospitals and Clinics
Study Sponsor Children's Mercy Hospital Kansas City
Collaborators University of Kansas
Investigators
Principal Investigator: William E Truog, MD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date August 2011