CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 target
Drug / intervention
Dexamethasone or other corticosteroiddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00007358
NCT00007358N/ACompleted
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Study of Dexamethasone in Neonatal Lupus Congenital Heart Block; PRIDE (PR Interval and Dexamethasone Evaluation) in Congenital Heart Block

NYU Langone Health·interventional·Posted Dec 18, 2000·Updated Mar 11, 2016

In Brief

A clinical study evaluating Dexamethasone or other corticosteroid for Congenital Heart Block and 3 related conditions. Completed, enrolled 150 participants across 4 sites.

Detailed Summary

Some newborns are born with congenital heart block (CHB), a condition occurring in babies with neonatal lupus. The first part of the study will test the effectiveness of fluorinated steroids, including dexamethasone, in improving the heart function and general health of newborns who have auto-antibody-associated CHB. The second part of this study will use ultrasound and heart monitoring to observe high-risk pregnant women and their fetuses during the third trimester of pregnancy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Block, Neonatal Lupus, Atrioventricular Nodal Dysfunction, Myocardial Injury
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2000
Enrollment StartOct 1, 2000
Primary CompletionApr 1, 2007
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 25.5 years ago

Interventions

Dexamethasone or other corticosteroiddrug

Administered during the third trimester of pregnancy