NCT00951366

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
885mo left

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jun 2008Jan 2099

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
89.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2099

Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

90.6 years

First QC Date

August 3, 2009

Last Update Submit

August 9, 2023

Conditions

Bronchopulmonary Disease

Keywords

premature birthneonatal respiratory distresschronic lung diseaseepidemiologicfactorsgenetic factors

Outcome Measures

Primary Outcomes (1)

  • Lung function

    Spirometry

    Lifetime

Study Arms (1)

Bronchopulmonary Dysplasia (BPD)

Other: Patient Registry

Interventions

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.

Bronchopulmonary Dysplasia (BPD)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Former preterm infants

You may qualify if:

  • Former preterm infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related 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.

    PMID: 34290373BACKGROUND

  • 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.

    PMID: 33971884RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs

MeSH Terms

Conditions

Premature BirthPulmonary Atelectasis

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Lystra Hayden, MD, MMSc

CONTACT

Lystra.Hayden@childrens.harvard.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
21 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Pediatrics

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

June 1, 2008

Primary Completion (Estimated)

January 1, 2099

Study Completion (Estimated)

January 1, 2099

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

US(1)