- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951366
Preterm Lung Patient Registry
August 9, 2023 updated by: Lystra Hayden, Boston Children's Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lystra Hayden, MD, MMSc
- Email: Lystra.Hayden@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- Lystra Hayden, MD, MMSc
- Phone Number: 617-355-1900
- Email: Lystra.Hayden@childrens.harvard.edu
-
Principal Investigator:
- Hayden Lystra, MD, MMSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Former preterm infants
Description
Inclusion Criteria:
- Former preterm infant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bronchopulmonary Dysplasia (BPD)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function
Time Frame: Lifetime
|
Spirometry
|
Lifetime
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Levin 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2008
Primary Completion (Estimated)
January 1, 2099
Study Completion (Estimated)
January 1, 2099
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimated)
August 4, 2009
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- X08-07-0335
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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