Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

Completed

Conditions studied: Preterm Birth, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity

In brief

The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and long-term breathing problems in preterm infants by investigating two interrelated biochemical pathways: the urea cycle-nitric oxide pathway and the glutathione pathway. The investigators hypothesize that prematurity-related limitations in the function of these important biochemical pathways contribute to respiratory disease risk over the first year of life.

Key facts

Study ID

NCT01460576

Run by

Vanderbilt University Medical Center

People needed

253

Starts

2011-09-01

Expected to finish

2016-12-01

Last updated by the study team

2017-05-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants who are less than or equal to 7 days old;
• Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days

You may not qualify if…

• The infant is not considered to be viable (decision made not to provide life-saving therapies);
• Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD);
• Structural abnormalities of the upper airway, lungs or chest wall;
• Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development;
• Family is unlikely to be available for long-term follow-up.

Where it is running

• Jackson Madison County General Hospital — Jackson, Tennessee, United States
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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