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BronchiolitisNCT00347880

Atrial and Brain Natriuretic Peptides in Bronchiolitis

An observational study of Bronchiolitis, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 37 weeks to 2 years
Conditions the study is for
Bronchiolitis
How many people
100 participants
Where
1 siteUnited States
Study dates
Sep 2004to Jul 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 37 weeks to 2 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • acute or chronic renal disease
  • chronic diuretic therapy
  • congenital cardiac disease
  • bronchopulmonary dysplasia
  • thyroid disease
  • pituitary abnormalities
Show all 10Show fewer
  • history of reactive airway disease
  • asthma
  • cystic fibrosis
  • recent history of receiving steroids

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida

    Gainesville, Florida, 32611

Other trials in United States

About this study

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.

Read the 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.

Conditions
Bronchiolitis
Keywords
Bronchiolitis, ANP, BNP, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Vasopressin, ADH, Pediatric, Respiratory Distress, Fluid Balance
Medical subject headings
Bronchiolitis, Diabetes Insipidus, Dyspnea

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2006 (estimated)
  2. Study startSep 2004
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00347880
Sponsor's protocol ID
IRB# 359-2004
Other IDs
GCRC 602
Status last verified
Mar 2012
First submitted
3 Jul 2006
Last updated
2 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiolitis, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.

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