CClinicalTrials.gg
RecruitingNCT00951366Updated Aug 14, 2023

Preterm Lung Patient Registry

An observational study in Bronchopulmonary Disease, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Boston Children's Hospital · Observational

From the registry’s dates

  • Started Jun 2008; still recruiting 18 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,500
Sex
All
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Study 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.

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.

02

Conditions studied

  • Bronchopulmonary Disease

Keywords

  • premature birth
  • neonatal respiratory distress
  • chronic lung disease
  • epidemiologicfactors
  • genetic factors
03

In context

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Former preterm infants

Eligibility criteria

Inclusion Criteria:

  • Former preterm infant
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
21 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Bronchopulmonary Dysplasia (BPD)

    Other: Patient Registry

Interventions

  • OtherPatient 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.

06

What researchers measure

Primary outcomes

  1. Lung function

    Spirometry

    Time frame: Lifetime

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Study locations

1 of 1 sites recruiting
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
    Recruiting
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References and documents

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 34290373 ↗
  • 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. PubMed 33971884 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00951366
Lead sponsor
Boston Children's Hospital
Collaborators
Brigham and Women's Hospital
Responsible party
Lystra Hayden (Instructor in Pediatrics, Boston Children's Hospital) — Principal investigator
First posted
Aug 4, 2009
Start date
Jun 2008
Primary completion
Jan 1, 2099 (estimated)
Completion
Jan 1, 2099 (estimated)
Last update
Aug 14, 2023

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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