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Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus

NCT00007358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-03-11

No results posted yet for this study

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.

Conditions

  • Congenital Heart Block
  • Neonatal Lupus
  • Atrioventricular Nodal Dysfunction
  • Myocardial Injury

Interventions

DRUG

Dexamethasone or other corticosteroid

Administered during the third trimester of pregnancy

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Jill P. Buyon · Hospital for Joint Diseases

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2007-04-30
Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00007358 on ClinicalTrials.gov