BronchiolitisNCT00347880
Atrial and Brain Natriuretic Peptides in Bronchiolitis
An observational study of Bronchiolitis, run by University of Florida at 1 site in United States.
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.
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.
- First posted4 Jul 2006 (estimated)
- Study startSep 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K. Alex Daneshmand, D.O., Principal investigator, University of Florida
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial and Brain Natriuretic Peptides in Bronchiolitis
- ClinicalTrials.gov ID
- NCT00347880
- Acronym / sponsor ID
- IRB# 359-2004
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, ANP, BNP, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Vasopressin, ADH, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 37 weeks to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between the ages of 37 weeks and 2 years old with evidence of bronchiolitis.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- acute or chronic renal disease
- chronic diuretic therapy
- congenital cardiac disease
- bronchopulmonary dysplasia
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K. Alex Daneshmand, D.O. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
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.