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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Antibodies; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria for Prospective Part of Trial:

• Mother must have anti-Ro and/or anti-La antibody

• Fetal bradyarrhythmia (slow, abnormal heart rhythm)

Exclusion Criteria for Prospective Part of Trial:

• Fetal heart abnormalities that may cause newborn CHB and could account for atrioventricular (AV) block

Inclusion Criteria for Observational Part of Trial:

• Mother must have anti-Ro and/or anti-La antibody

• Fetus must have documented normal heartbeat prior to the 16th week of pregnancy

• Fetus must have a structurally normal heart

• Mother must be enrolled during the 16th, 17th, or 18th week of pregnancy

Exclusion Criteria for Observational Part of Trial:

• Mother is taking more than 10 mg of prednisone per day