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Preterm Lung Patient Registry

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ClinicalTrials.gov Identifier: NCT00951366
Recruitment Status : Recruiting
First Posted : August 4, 2009
Last Update Posted : June 6, 2022
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Lystra Hayden, Boston Children's Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Bronchopulmonary Disease Other: Patient Registry

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 21 Years
Official Title: Preterm Lung Patient Registry
Study Start Date : June 2008
Estimated Primary Completion Date : January 1, 2099
Estimated Study Completion Date : January 1, 2099


Group/Cohort Intervention/treatment
Bronchopulmonary Dysplasia (BPD) Other: Patient Registry
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.




Primary Outcome Measures :
  1. Lung function [ Time Frame: Lifetime ]
    Spirometry


Biospecimen Retention:   Samples With DNA
Buccal swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Former preterm infants
Criteria

Inclusion Criteria:

  • Former preterm infant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951366


Contacts
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Contact: Lystra Hayden, MD, MMSc Lystra.Hayden@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lystra Hayden, MD, MMSc    617-355-1900    Lystra.Hayden@childrens.harvard.edu   
Principal Investigator: Hayden Lystra, MD, MMSc         
Sponsors and Collaborators
Boston Children's Hospital
Brigham and Women's Hospital
Additional Information:

Publications of Results:
Other Publications:
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Responsible Party: Lystra Hayden, Instructor in Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00951366    
Other Study ID Numbers: X08-07-0335
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Keywords provided by Lystra Hayden, Boston Children's Hospital:
premature birth
neonatal respiratory distress
chronic lung disease
epidemiologicfactors
genetic factors