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Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus Clinical research trials and Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus. Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus clinical trial. Test subjects typically obtain the finest healthcare available for their Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus  Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus
Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus
For Condition: Congenital heart block,Neonatal lupus,Atrioventricular nodal dysfunction,Myocardial injury
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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 fluoridated 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/50 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria for Interventional Part of Trial: - Mother must have anti-Ro and/or anti-La antibody - Fetal bradyarrhythmia (slow, abnormal heart rhythm) Exclusion Criteria for Interventional 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
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
JillBuyon, Principal Investigator, Hospital for Joint Diseases
Hospital for Joint Diseases *Recruiting*
New York City, New York, 10003
United States
Recruiting Elaine Kiang 212-598-6513
St Lukes-Roosevelt Hospital Center *Recruiting*
New York City, New York, 10019
United States
Recruiting Deborah Friedman 212-523-6993
New York University Medical Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Elaine Kiang 212-598-6513
Yale University Medical Center *Recruiting*
New Haven, Connecticut, 06520
United States
Recruiting Joshua Copel 203-785-2671
Additional Information:
Study ID Numbers: NIAMS-055; R01 AR46265
Study Start Date: October 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007358
Other Neonatal Lupus Studies:
1. Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus
Related Studies:
Other Neonatal lupus Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus
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