Bronchopulmonary DysplasiaGRPNCT01748565
Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia and Prematurity, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to identify biological markers that might predict premature infants who are at a higher risk for developing BPD, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Bronchopulmonary Dysplasia, Prematurity
- How many people
- 260 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Aug 2016
- 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 Up to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital
Who may be able to join
- Gestational age at birth 23-0/7 to 27-6/7 weeks post-menstrual age
Who cannot join
- Are not considered to be viable (decision made not to provide life-saving therapies)
- Have congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
- Have structural abnormalities of the upper airway, lungs or chest wall
- Have other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
- Unlikely to return to the clinic for follow-up visits
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Riley Children's Hospital
Indianapolis, Indiana, 46202-5225
About this study
The purpose of this study is to identify biological markers that might predict premature infants who are at a higher risk for developing BPD, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital.
Read the detailed description
Bronchopulmonary dysplasia (BPD) is a common form of lung injury that can be triggered by premature birth and the unavoidable exposures to treatments regularly used for premature infants,including mechanical ventilation and oxygen as well as conditions that occur frequently among premature infants including infection. Almost all infants who are born prematurely are exposed to either mechanical ventilation, extra oxygen, and many will develop at least one infection; however, not all premature infants will develop BPD. There is currently no way to identify those infants who are at risk for developing BPD, nor are there prognostic or diagnostic tests to determine the severity of lung disease in the first year after discharge from the hospital.
The application of UPLC-tandem mass spectrometry for quantification of urinary biomarkers of oxidative stress is an important technical innovation that will permit sensitive and reproducible analyses of urinary biomarkers with minimal sample preparation to better define disease phenotypes. Establishing a direct correlation between biomarkers of oxidative stress and GRP will accelerate investigation into the mechanisms leading to chronic pediatric lung disease and childhood origins of pulmonary disease.
- Conditions
- Bronchopulmonary Dysplasia, Prematurity
- Keywords
- biomarkers, oxidative stress, BPD, prematurity
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| premature infants | Infants born prematurely between 23-0/7 and 27-6/7 weeks post-menstrual age with and without bronchopulmonary dysplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Measured: day-of-life 1-4
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Measured: 36 weeks post-menstrual age
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Measured: 4-6 months corrected age
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Measured: 12-14 months corrected age
infant pulmonary function tests
The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD
Measured: 4-6 months corrected age
infant pulmonary function tests
The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD
Measured: 12-14 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Charles M Cotten, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748565
- Sponsor's protocol ID
- Pro00025462
- Acronym
- GRP
- Status last verified
- Aug 2016
- First submitted
- 29 Oct 2012
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT01748565
- Acronym / sponsor ID
- GRP / Pro00025462
- Conditions
- Bronchopulmonary Dysplasia, Prematurity
- Keywords
- biomarkers, oxidative stress, BPD, prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Indiana University, University of North Carolina, Chapel Hill
- Study start
- May 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Dec 2012 (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 identify biological markers that might predict premature infants who are at a higher risk for developing BPD, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital.
Detailed description
Bronchopulmonary dysplasia (BPD) is a common form of lung injury that can be triggered by premature birth and the unavoidable exposures to treatments regularly used for premature infants,including mechanical ventilation and oxygen as well as conditions that occur frequently among premature infants including infection. Almost all infants who are born prematurely are exposed to either mechanical ventilation, extra oxygen, and many will develop at least one infection; however, not all premature infants will develop BPD. There is currently no way to identify those infants who are at risk for developing BPD, nor are there prognostic or diagnostic tests to determine the severity of lung disease in the first year after discharge from the hospital.
The application of UPLC-tandem mass spectrometry for quantification of urinary biomarkers of oxidative stress is an important technical innovation that will permit sensitive and reproducible analyses of urinary biomarkers with minimal sample preparation to better define disease phenotypes. Establishing a direct correlation between biomarkers of oxidative stress and GRP will accelerate investigation into the mechanisms leading to chronic pediatric lung disease and childhood origins of pulmonary disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature infants | – | –Infants born prematurely between 23-0/7 and 27-6/7 weeks post-menstrual age with and without bronchopulmonary dysplasia |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital
Key inclusion criteria (1 listed)
- Gestational age at birth 23-0/7 to 27-6/7 weeks post-menstrual age
Key exclusion criteria (5 listed)
- Are not considered to be viable (decision made not to provide life-saving therapies)
- Have congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
- Have structural abnormalities of the upper airway, lungs or chest wall
- Have other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
- Unlikely to return to the clinic for follow-up visits
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
urine GRP levels
Time frame: day-of-life 1-4
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
urine GRP levels
Time frame: 36 weeks post-menstrual age
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
urine GRP levels
Time frame: 4-6 months corrected age
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
urine GRP levels
Time frame: 12-14 months corrected age
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
infant pulmonary function tests
Time frame: 4-6 months corrected age
The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD
infant pulmonary function tests
Time frame: 12-14 months corrected age
The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD
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 12 Apr 2024.
Related trials for Bronchopulmonary Dysplasia
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Charles M Cotten, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Prematurity, run by Duke University at 2 sites 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 1 inclusion and 5 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
urine GRP levels (time frame: day-of-life 1-4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 Apr 2024.