Preterm Lung Patient Registry

Bronchopulmonary Disease Clinical Trial

Official title:

Preterm Lung Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00951366
• Other study ID #: X08-07-0335
• Status: Recruiting
• Start date: June 2008
• Est. completion date: January 1, 2099

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: Lystra Hayden, MD, MMSc
• Email: Lystra.Hayden[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 1, 2099
• Est. primary completion date: January 1, 2099
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Former preterm infant

Related Conditions & MeSH terms

• Bronchopulmonary Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function	Spirometry	Lifetime