Genetic Variants and Susceptibility to Diseases of Prematurity in Very Low Birth-Weight Infants

NCT00710112 | Recruiting

• 1 other identifier: PRO44242
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if sequence variations in genes involved in the development and function of vulnerable organs increases susceptibility to chronic lung disease (CLD) and other diseases affecting premature infants, such as necrotizing enterocolitis (NEC), sepsis, patent ductus arteriosus (PDA) and intraventricular hemorrhage (IVH). The study will also determine whether measurement of certain biomarkers in serum will identify infants who will develop these complications of prematurity. Previous studies from this institution and others have identified genetic variants in some genes, such as toll like receptor genes are associated with higher risk of CLD or NEC. The interaction of these variants with other gene variants that can influence the risk of these diseases remains unclear.

Conditions

Chronic Lung Disease

Keywords

CLD; VLBW infants; Toll like Receptors; Biomarkers

Outcome Measures

Primary Outcomes (1)

• To determine if small variations in certain genes predispose infants to the development of chronic lung disease and other diseases of prematurity

  participants will be followed for the duration of hospital stay, an expected average of 6 to 8 weeks

Study Arms (1)

VLBW

infants less than 1500 grams at birth

Genetic: gene variations

Interventions

gene variations GENETIC

comparing variations in genes in infants who develop chronic lung disease and other diseases of prematurity and those who do not.

Also known as: toll like receptors, biomarkers

VLBW

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Infants born weighing less than 1500 grams

You may qualify if:

• Infants born weighing less than 1500 grams

You may not qualify if:

• Infants born with congenital heart disease (other than patent ductus arteriosus)
• major congenital anomalies of the GI tract, respiratory tract, or kidneys

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Interventions

Toll-Like Receptors; Biomarkers

Intervention Hierarchy (Ancestors)

Receptors, Pattern Recognition; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• G. Ganesh Konduri, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G. Ganesh Konduri, MD

CONTACT

414.266.6820; gkonduri@mcw.edu

Kathleen M Meskin, BSN

CONTACT

414.337.7171; kmeskin@mcw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Neonatology; Professor

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: July 4, 2008
• Study Start: June 1, 2006
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)