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Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus
This study is currently recruiting patients.
Sponsored by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Purpose
Some newborns are born with congenital heart block (CHB), a temporary 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.
Condition | Treatment or Intervention |
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Congenital heart block Neonatal lupus Atrioventricular nodal dysfunction Myocardial injury |
Drug: Dexamethasone or other corticosteroid |
MedlinePlus related topics: Arrhythmia; Congenital Heart Disease; Connective Tissue Disorders; Skin Diseases
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Official Title: Study of Dexamethasone in Neonatal Lupus Congenital Heart Block; PRIDE (PR Interval and Dexamethasone Evaluation) in Congenital Heart Block
Expected Total Enrollment: 150
Study start: October 2000;
Study completion: October 2004
CHB is a temporary abnormal condition of newborns strongly associated with maternal antibodies to SSA/Ro and SSB/La ribonucleoproteins. This study hopes to clarify the causes of CHB and develop appropriate treatments. The study has two parts.
The first part of the study will be interventional; it will determine if fluorinated steroids given to women prior to birth improves the heart function and well-being of their newborns. This part of the study will evaluate fetuses diagnosed in utero with CHB during the third trimester of pregnancy. Diagnosis of CHB must occur at least 6 weeks before the baby is born to allow for sufficient data collection. It will be the decision of the physician and the mother as to whether a steroid will be administered. Fetuses will be evaluated before delivery by electrocardiogram (ECG) to detect abnormal fluid collection and by ultrasound to monitor heartbeat. After birth, newborns will be assessed for overall pumping strength of the heart and for abnormal heartbeat. Blood will be drawn from the mother at the time of enrollment and during delivery. Visits will occur over a span of approximately 5 months.
The second part of this study will be observational; the purpose is to identify classic indicators of heartbeat dysfunction and heart injury in newborns with CHB. The goal of this part of the study is to better understand the stages of heart injury, the role of anti-Ro/La antibodies in CHB, and procedures that may reverse heart block. Mothers considered to be at high risk for having a child with CHB will undergo weekly ECGs from 16 weeks into their pregnancy until Week 28, then will have an ECG every other week from Week 28 through Week 34. There will be a total of 15 visits to conduct these ECGs. Blood will be drawn at the first ECG visit and during delivery. Visits will occur over a span of 4 months.
For both parts of the study, babies will undergo ECGs after delivery and at one year of age. Additional tests not related to the study may be ordered by the physician.
Eligibility
Ages Eligible for Study: 16 Years - 50 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria for Interventional Part of Trial:
Exclusion Criteria for Interventional Part of Trial:
Inclusion Criteria for Observational Part of Trial:
Exclusion Criteria for Observational Part of Trial:
Location and Contact Information
More Information
Publications
Buyon JP, Clancy RM. Neonatal lupus syndromes. Curr Opin Rheumatol. 2003 Sep; 15(5): 535-41. Review.
Friedman DM, Duncanson LJ, Glickstein J, Buyon JP. A review of congenital heart block. Images in Paediatric Cardiology. 16:36-48, 2003.
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