Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

NCT01460576 | Completed DMC

• 2 other identifiers: 1108331U01HL101456
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Preterm Birth; Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity

Keywords

prematurity; respiratory disease; bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• Respiratory morbidity

  Need for oxygen, respiratory medications, hospital admissions for respiratory disease or a positive response in at least 1 of 4 morbidity domains during at least 2 separate parental interviews.

  one year corrected age

Secondary Outcomes (1)

• bronchopulmonary dysplasia

  36 weeks corrected age

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants admitted to the Neonatal Intensive Care Unit who are \< 29 weeks gestational age

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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Jackson Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

• Vadivel A, Aschner JL, Rey-Parra GJ, Magarik J, Zeng H, Summar M, Eaton F, Thebaud B. L-citrulline attenuates arrested alveolar growth and pulmonary hypertension in oxygen-induced lung injury in newborn rats. Pediatr Res. 2010 Dec;68(6):519-25. doi: 10.1203/PDR.0b013e3181f90278.

  PMID: 20805789 BACKGROUND

• Fike CD, Sidoryk-Wegrzynowicz M, Aschner M, Summar M, Prince LS, Cunningham G, Kaplowitz M, Zhang Y, Aschner JL. Prolonged hypoxia augments L-citrulline transport by system A in the newborn piglet pulmonary circulation. Cardiovasc Res. 2012 Aug 1;95(3):375-84. doi: 10.1093/cvr/cvs186. Epub 2012 Jun 6.

  PMID: 22673370 BACKGROUND

• Ananthakrishnan M, Barr FE, Summar ML, Smith HA, Kaplowitz M, Cunningham G, Magarik J, Zhang Y, Fike CD. L-Citrulline ameliorates chronic hypoxia-induced pulmonary hypertension in newborn piglets. Am J Physiol Lung Cell Mol Physiol. 2009 Sep;297(3):L506-11. doi: 10.1152/ajplung.00017.2009. Epub 2009 Jul 17.

  PMID: 19617312 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

saliva for DNA, plasma, red blood cells, urine and tracheal aspirates

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Respiration Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Judy L. Aschner, MD

  Albert Einstein College of Medicine; Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asscoc. Professor

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 27, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (2)