Atrial and Brain Natriuretic Peptides in Bronchiolitis

The purpose of this study is to collect information about what happens to certain chemicals produced in the body called hormones during respiratory infections such as bronchiolitis. Bronchiolitis is an infection of small airways in the lungs caused by a virus. This infection, which causes swelling and injury in the lungs, is commonly seen in infants and children less than 2 years of age.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis

Detailed Description

Intravascular volume and serum osmolality are tightly regulated by a balance of various neurohumoral mediators. In critical illness, these regulatory mediators may be modified by disease or treatment, either benefiting or harming the patient. Such regulatory mediators of intravascular volume and fluid balance include atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP) and vasopressin (also called antidiuretic hormone-ADH). Although well studied in adult cardiac patients, these neurohormones have not been investigated in pediatric respiratory diseases such as bronchiolitis, a common cause of admission to the Pediatric Intensive Care Unit (PICU). Understanding the effects of pediatric respiratory diseases and treatment interventions on the concentrations of these neurohormonal regulators such as ANP and BNP is a crucial first step in formulating more effective fluid therapy. For example, some patients with bronchiolitis have elevated ADH levels. Increased ADH concentration predisposes to fluid retention and increases the risk of pulmonary edema. Since ANP and BNP antagonize the action of ADH, simultaneous measurement of all three hormones may help elucidate the mechanisms of fluid balance in bronchiolitis.

The study hypothesis is that the plasma concentrations of ANP and BNP in infants and children with bronchiolitis are inversely associated with ADH concentration and lung hyperinflation. Furthermore, plasma concentrations of ANP and BNP in bronchiolitis are associated directly with increased oxygen requirement and positive fluid balance. The significance of this study is to better understand the relationship between various neurohormones that regulate intravascular fluid volume in patients with respiratory failure and bronchiolitis. The understanding of this complex relationship has the potential to improve fluid/diuretic therapy and patient outcome with severe respiratory distress in the future.

We plan to enroll 100 patients in this study. The population will be infants and children between 37 weeks and 2 years of age (corrected for gestational age). 50 patients with bronchiolitis will be enrolled to collect ANP, BNP, and ADH plasma levels along with serum osmolality and urine osmolality for up to 5 consecutive days in Shands Children's Hospital.

Comparison: 50 control patients will be enrolled to record normal baseline plasma ANP, BNP, and ADH at the time of admission in Shands Hospital surgical center at the University of Florida.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children between the ages of 37 weeks and 2 years old with evidence of bronchiolitis.

Description

Inclusion Criteria:

• child between 37 weeks and 2 years old
• chest X-ray evidence of peri-bronchial cuffing or air trapping
• Two of the Following:
• history or evidence of nasal secretion
• inter-and/or sub-costal retractions
• evidence of wheezing

Exclusion Criteria:

• acute or chronic renal disease
• chronic diuretic therapy
• congenital cardiac disease
• bronchopulmonary dysplasia
• thyroid disease
• pituitary abnormalities
• history of reactive airway disease
• asthma
• cystic fibrosis
• recent history of receiving steroids

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: K. Alex Daneshmand, D.O., University of Florida

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: July 3, 2006
• First Submitted That Met QC Criteria: July 3, 2006
• First Posted (Estimate): July 4, 2006

Study Record Updates

• Last Update Posted (Estimate): March 2, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Pediatric; Vasopressin; Fluid Balance; ADH; BNP; Bronchiolitis; Respiratory Distress; ANP; Brain Natriuretic Peptide; Atrial Natriuretic Peptide
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: IRB# 359-2004; GCRC 602