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

Completed

• Conditions: Brain Injury; Respiratory Failure; Lung Disease; Necrotizing Enterocolitis

• Registration Number: NCT00315263
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-14
• Study First Posted: 2006-04-18
• Primary Completion: 2008-10
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States

Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States