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

This study is currently recruiting participants.

Verified by Children's Mercy Hospital Kansas City, April 2008

Sponsors and Collaborators:	Children's Mercy Hospital Kansas City University of Kansas
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00315263

Purpose

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
Lung Disease Brain Injury Necrotizing Enterocolitis Respiratory Failure

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

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

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole Blood

Estimated Enrollment:	450
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2009

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Intensive Care Nursery

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315263

Contacts

Contact: William E Truog, MD	816-234-3592	wtruog@cmh.edu
Contact: Michael Norberg, BS, MDiv	816-235-1981	mnorberg@cmh.edu

Locations

United States, Missouri
Children's Mercy Hospitals and Clinics	Recruiting
Kansas City, Missouri, United States, 64108
Contact: William E Truog, MD 816-234-3592 wtruog@cmh.edu
Contact: Michael Norberg, BS, MDiv 816-235-1981 mnorberg@cmh.edu
Principal Investigator: William E Truog, MD
Truman Medical Center	Recruiting
Kansas City, Missouri, United States, 64108
Contact: William E Truog, MD 816-234-3592 WTruog@cmh.edu
Contact: Michael Norberg, BS, MDiv 816-235-1981 mnorberg@cmh.edu
Principal Investigator: William E Truog, MD

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

University of Kansas

Investigators

Principal Investigator:

William E Truog, MD

Children's Mercy Hospital Kansas City

More Information

Official Web Address of sponsoring organization This link exits the ClinicalTrials.gov site

Responsible Party:	The Children's Mercy Hospitals and Clinics ( William Truog, MD, Principal Investigator )
Study ID Numbers:	01.3965
Study First Received:	April 14, 2006
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00315263
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

DNA
Genomics
SNPs
Neonatology

Chronic Lung Disease
Periventricular Brain Injury
Hypoxic Respiratory Failure

Study placed in the following topic categories:

Craniocerebral Trauma
Gastrointestinal Diseases
Respiration Disorders
Wounds and Injuries
Necrotizing enterocolitis
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Intestinal Diseases

Brain Diseases
Enterocolitis
Respiratory Insufficiency
Digestive System Diseases
Respiratory Tract Diseases
Lung Diseases
Enterocolitis, Necrotizing
Brain Injuries
Gastroenteritis

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009