Status:
COMPLETED
Preventive IVIG Therapy for Congenital Heart Block
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Lupus Research Alliance
Conditions:
Congenital Heart Block
Neonatal Lupus
Eligibility:
FEMALE
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
Neonatal lupus (NL) is the name given to a group of conditions that can affect the babies of mothers who have certain autoantibodies against components of the body's cells that are called SSA/Ro and S...
Detailed Description
Perhaps the strongest clinical association with autoantibodies against SSA/Ro-SSB/La is the development of congenital heart block (CHB) in an offspring, an alarming prospect facing 2% of primigravid m...
Eligibility Criteria
Inclusion
- Mother must currently have an intrauterine pregnancy of less than 12 weeks.
- Mother must have antibodies to SSA/Ro and/or SSB/La (will be confirmed in the clinical immunology laboratory at the Principal Investigator's institution, the NYU-Hospital for Joint Diseases).
- Mother can be asymptomatic or have any rheumatic disease (such as lupus, Sjogren syndrome or other).
- Mother must have had a previous child with one of the following: (a) congenital heart block (any degree) documented by EKG if live birth and/or echocardiogram if fetal demise; (b) characteristic neonatal lupus rash confirmed by photograph revealing annular lesions (evaluated by the PI), dermatology note, and/or biopsy; (c) congenital heart block and rash.
- Mother may be taking 20 mg prednisone per day or less.
Exclusion
- Mother does not have antibodies to either SSA/Ro or SSB/La.
- Mother is taking greater than 20 mg prednisone per day.
- Mother has any condition that would contraindicate the use of IVIG: (a) prior serious reaction to IVIG infusion; (b) known IgA deficiency; (c) intolerance of volume load, e.g., congestive heart failure; (d) nephrotic syndrome.
- Identification in the fetus of any of the following structural lesions considered causal for congenital heart block: (a) atrioventricular septal defects; (b) single ventricle; (c) developmental tricuspid valve disease; (d) L-transposition of the great arteries; (e) heterotaxia.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00460928
Start Date
April 1 2007
End Date
June 1 2009
Last Update
September 30 2019
Active Locations (2)
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1
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
2
New York University School of Medicine / NYU-Hospital for Joint Diseases
New York, New York, United States, 10016