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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT00710112
Status
Recruiting

Conditions

  • Chronic Lung Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 30, 2006
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
1,100 participants (estimated)

Arms

  • Arm: VLBW
    infants less than 1500 grams at birth

Primary Outcome Measure

To determine if small variations in certain genes predispose infants to the development of chronic lung disease and other diseases of prematurity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 to 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's WisconsinMilwaukeeWisconsin53226
G. Ganesh Konduri, MD
414-266-6820
Kathleen Meskin, RN, BSN
414-337-7171
G. Ganesh Konduri, MD (PRINCIPAL_INVESTIGATOR)

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