Bronchopulmonary DiseaseNCT00951366
Preterm Lung Patient Registry
An observational study of Bronchopulmonary Disease, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of the Preterm Lung Patient Registry is to collect data on individuals with neonatal lung disease to better understand the illness and ultimately improve their care and survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchopulmonary Disease
- What is being tested?
- Patient Registry
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to 1 Jan 2099
- How long will I take part?
- 21 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Former preterm infants
Who may be able to join
- Former preterm infant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lystra Hayden, MD, MMSc contact
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Lystra Hayden, MD, MMSc, 617-355-1900, Lystra.Hayden@childrens.harvard.edu
Hayden Lystra, MD, MMSc
About this study
The goal of the Preterm Lung Patient Registry is to collect data on individuals with neonatal lung disease to better understand the illness and ultimately improve their care and survival. The Patient Registry was established in 2008 as a means to monitor important trends in the BPD population and to improve understanding, treatment, and survival.
Read the detailed description
The Preterm Lung Patient Registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period. The Patient Registry is used by both clinicians and researchers to better understand BPD and to improve care of individuals with BPD. It is used to assess phenotype and genotype information from former preterm infants with lung disease. Data in the Patient Registry will be analyzed and an regular report of BPD health trends will be created. Using this information, BPD clinicians can address quality improvement initiatives, and examine changing health care issues, including nutritional status, infection control, pulmonary treatment, metabolic and associated genetic variants. The Patient Registry will also play an important role in directing clinical care and in the design of clinical research studies. Researchers use the registry to help in investigating various aspects of neonatal lung diseases like BPD, including medications, diagnostic procedures, and eligibility for clinical trials.
- Conditions
- Bronchopulmonary Disease
- Being tested
- Patient Registry
- Keywords
- premature birth, neonatal respiratory distress, chronic lung disease, epidemiologicfactors, genetic factors
- Medical subject headings
- Premature Birth, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient RegistryOther
The CHILD Clinic Patient Registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period.
| Study group | Role | What they receive |
|---|---|---|
| Bronchopulmonary Dysplasia (BPD) | Not described Receives: Other: Patient Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Spirometry
Measured: Lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJun 2008
- Primary completion1 Jan 2099 (estimated)
- Study completion1 Jan 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 21 Years
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Lystra Hayden, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951366
- Sponsor's protocol ID
- X08-07-0335
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2009
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Annesi CA, Levin JC, Litt JS, Sheils CA, Hayden LP. Long-term respiratory and developmental outcomes in children with bronchopulmonary dysplasia and history of tracheostomy. J Perinatol. 2021 Nov;41(11):2645-2650. doi: 10.1038/s41372-021-01144-0. Epub 2021 Jul 21.
PubMed 34290373Levin JC, Sheils CA, Gaffin JM, Hersh CP, Rhein LM, Hayden LP. Lung function trajectories in children with post-prematurity respiratory disease: identifying risk factors for abnormal growth. Respir Res. 2021 May 10;22(1):143. doi: 10.1186/s12931-021-01720-0.
PubMed 33971884
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Lung Patient Registry
- ClinicalTrials.gov ID
- NCT00951366
- Acronym / sponsor ID
- X08-07-0335
- Conditions
- Bronchopulmonary Disease
- Keywords
- premature birth, neonatal respiratory distress, chronic lung disease, epidemiologicfactors, genetic factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jun 2008 (actual)
- Primary completion
- 1 Jan 2099 (estimated)
- Study completion
- 1 Jan 2099 (estimated)
- First posted
- 4 Aug 2009 (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 goal of the Preterm Lung Patient Registry is to collect data on individuals with neonatal lung disease to better understand the illness and ultimately improve their care and survival. The Patient Registry was established in 2008 as a means to monitor important trends in the BPD population and to improve understanding, treatment, and survival.
Detailed description
The Preterm Lung Patient Registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period. The Patient Registry is used by both clinicians and researchers to better understand BPD and to improve care of individuals with BPD. It is used to assess phenotype and genotype information from former preterm infants with lung disease. Data in the Patient Registry will be analyzed and an regular report of BPD health trends will be created. Using this information, BPD clinicians can address quality improvement initiatives, and examine changing health care issues, including nutritional status, infection control, pulmonary treatment, metabolic and associated genetic variants. The Patient Registry will also play an important role in directing clinical care and in the design of clinical research studies. Researchers use the registry to help in investigating various aspects of neonatal lung diseases like BPD, including medications, diagnostic procedures, and eligibility for clinical trials.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 21 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchopulmonary Dysplasia (BPD) | – | Other: Patient Registry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Former preterm infants
Key inclusion criteria (1 listed)
- Former preterm infant
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient RegistryThe CHILD Clinic Patient Registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period. | Other | Bronchopulmonary Dysplasia (BPD) |
Primary outcome
Lung function
Time frame: Lifetime
Spirometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 34290373Annesi CA, Levin JC, Litt JS, Sheils CA, Hayden LP. Long-term respiratory and developmental outcomes in children with bronchopulmonary dysplasia and history of tracheostomy. J Perinatol. 2021 Nov;41(11):2645-2650. doi: 10.1038/s41372-021-01144-0. Epub 2021 Jul 21.
- Results publication: PubMed 33971884Levin JC, Sheils CA, Gaffin JM, Hersh CP, Rhein LM, Hayden LP. Lung function trajectories in children with post-prematurity respiratory disease: identifying risk factors for abnormal growth. Respir Res. 2021 May 10;22(1):143. doi: 10.1186/s12931-021-01720-0.
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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.
Lystra Hayden, MD, MMSc contact
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 Bronchopulmonary Disease, run by Boston Children's Hospital 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 14 Aug 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lystra Hayden, MD, MMSc (Lystra.Hayden@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: Lifetime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00951366, which also lists 2 linked publications.
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 14 Aug 2023.