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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants born weighing less than 1500 grams

Disqualifiers

Infants born with congenital heart disease (other than patent ductus arteriosus)

major congenital anomalies of the GI tract, respiratory tract, or kidneys

Trial population

Infants born weighing less than 1500 grams

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • gene variations

    Genetic

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

Treatment groups

1,100 Participants
are divided into 1 treatment group
Group A: VLBW1 intervention

Trial outcomes

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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