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

This study has been completed.
University of Kansas Medical Center
Information provided by:
Children's Mercy Hospital Kansas City Identifier:
First received: April 14, 2006
Last updated: August 25, 2011
Last verified: August 2011
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).

Lung Disease
Brain Injury
Necrotizing Enterocolitis
Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genomics, SNPs, and Clinical Neonatology

Resource links provided by NLM:

Further study details as provided by Children's Mercy Hospital Kansas City:

Biospecimen Retention:   Samples With DNA
Whole Blood

Enrollment: 63
Study Start Date: April 2006
Study Completion Date: July 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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.

Genders Eligible for Study:   Both
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00315263

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 Medical Center
Principal Investigator: William E Truog, MD Children's Mercy Hospital Kansas City
  More Information

Additional Information:
Responsible Party: William Truog, MD, Principal Investigator, The Children's Mercy Hospitals and Clinics Identifier: NCT00315263     History of Changes
Other Study ID Numbers: 01.3965 
Study First Received: April 14, 2006
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Chronic Lung Disease
Periventricular Brain Injury
Hypoxic Respiratory Failure

Additional relevant MeSH terms:
Brain Injuries
Enterocolitis, Necrotizing
Lung Diseases
Respiratory Insufficiency
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on May 05, 2016