NCT01516398

Brief Summary

A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes and death for premature infants. Infants with BPD are also at high risk for pulmonary hypertension (PH)-an important contributor to their condition. Previous research has suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary disease. This study aims to investigate the incidence of PH and levels of ET-1 among premature babies with BPD. It will also potentially allow us to focus further research efforts and treatment towards these infants, some of our sickest patients at LPCH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

7.7 years

First QC Date

January 19, 2012

Last Update Submit

September 23, 2021

Conditions

Bronchopulmonary Dysplasia (BPD)Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Infant develops BPD

    36 weeks of age

Secondary Outcomes (1)

  • Infant develops PH

    36 weeks

Study Arms (2)

Preterm infants

No interventions were performed. Group consisted of preterm infants enrolled in the study.

Term control infants

No interventions were performed. Group consisted of term infants enrolled in the study to serve as controls for the preterm infant group.

Eligibility Criteria

AgeUp to 30 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

LPCH premature neonates

You may qualify if:

  • Premature Infants (\<30 weeks EGA)

You may not qualify if:

  • Major congenital malformations (cardiac, respiratory, gastrointestinal)
  • congenital infection, and/or
  • known genetic syndromes (i.e. trisomy 21)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

El Camino Hospital

Mountain View, California, 94040, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Bronchopulmonary DysplasiaHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Christine Johnson, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 24, 2012

Study Start

July 1, 2011

Primary Completion

March 10, 2019

Study Completion

March 10, 2019

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Publication

Locations

US(2)