Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus
NCT ID: NCT00007358
Last Updated: 2016-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
150 participants
INTERVENTIONAL
2000-10-31
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
NCT04559425
FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)
NCT03489993
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
NCT03406884
The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study
NCT05300802
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
NCT00850720
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The first part of the study will be prospective; 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 24, then will have an ECG every other week from Week 24 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Depending on patient and physician decision, a steroid may be administered during pregnancy.
Dexamethasone or other corticosteroid
Administered during the third trimester of pregnancy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone or other corticosteroid
Administered during the third trimester of pregnancy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Fetal bradyarrhythmia (slow, abnormal heart rhythm)
* 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
* Mother is taking more than 10 mg of prednisone per day
16 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
New York University Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jill P. Buyon
Role: PRINCIPAL_INVESTIGATOR
Hospital for Joint Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale University Medical Center
New Haven, Connecticut, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Hospital for Joint Diseases
New York, New York, United States
New York University Medical Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saleeb S, Copel J, Friedman D, Buyon JP. Comparison of treatment with fluorinated glucocorticoids to the natural history of autoantibody-associated congenital heart block: retrospective review of the research registry for neonatal lupus. Arthritis Rheum. 1999 Nov;42(11):2335-45. doi: 10.1002/1529-0131(199911)42:113.0.CO;2-3.
Glickstein JS, Buyon J, Friedman D. Pulsed Doppler echocardiographic assessment of the fetal PR interval. Am J Cardiol. 2000 Jul 15;86(2):236-9. doi: 10.1016/s0002-9149(00)00867-5. No abstract available.
Buyon JP, Waltuck J, Kleinman C, Copel J. In utero identification and therapy of congenital heart block. Lupus. 1995 Apr;4(2):116-21. doi: 10.1177/096120339500400207.
Copel JA, Buyon JP, Kleinman CS. Successful in utero therapy of fetal heart block. Am J Obstet Gynecol. 1995 Nov;173(5):1384-90. doi: 10.1016/0002-9378(95)90621-5.
Askanase AD, Friedman DM, Copel J, Dische MR, Dubin A, Starc TJ, Katholi MC, Buyon JP. Spectrum and progression of conduction abnormalities in infants born to mothers with anti-SSA/Ro-SSB/La antibodies. Lupus. 2002;11(3):145-51. doi: 10.1191/0961203302lu173oa.
Friedman DM, Rupel A, Glickstein J, Buyon JP. Congenital heart block in neonatal lupus: the pediatric cardiologist's perspective. Indian J Pediatr. 2002 Jun;69(6):517-22. doi: 10.1007/BF02722656.
Friedman D, Buyon J, Kim M, Glickstein JS. Fetal cardiac function assessed by Doppler myocardial performance index (Tei Index). Ultrasound Obstet Gynecol. 2003 Jan;21(1):33-6. doi: 10.1002/uog.11.
Askanase A, Friedman D, Glickstein J, Kim M, Buyon J. Potential Therapeutic window from normal heart rate (NHR) to advanced heart blcok and early detection of firts degree block by echocardiographic measurement of the mechanical PR interval. Arthritis Rheum. 2002; 46(suppl);5321.
Buyon JP, Clancy RM. Neonatal lupus: review of proposed pathogenesis and clinical data from the US-based Research Registry for Neonatal Lupus. Autoimmunity. 2003 Feb;36(1):41-50. doi: 10.1080/0891693031000067340.
Buyon JP, Clancy RM. Neonatal lupus syndromes. Curr Opin Rheumatol. 2003 Sep;15(5):535-41. doi: 10.1097/00002281-200309000-00003.
Buyon JP, Hiebert R, Copel J, Craft J, Friedman D, Katholi M, Lee LA, Provost TT, Reichlin M, Rider L, Rupel A, Saleeb S, Weston WL, Skovron ML. Autoimmune-associated congenital heart block: demographics, mortality, morbidity and recurrence rates obtained from a national neonatal lupus registry. J Am Coll Cardiol. 1998 Jun;31(7):1658-66. doi: 10.1016/s0735-1097(98)00161-2.
Friedman D, Duncanson Lj, Glickstein J, Buyon J. A review of congenital heart block. Images Paediatr Cardiol. 2003 Jul;5(3):36-48.
Friedman DM, Kim MY, Copel JA, Davis C, Phoon CK, Glickstein JS, Buyon JP; PRIDE Investigators. Utility of cardiac monitoring in fetuses at risk for congenital heart block: the PR Interval and Dexamethasone Evaluation (PRIDE) prospective study. Circulation. 2008 Jan 29;117(4):485-93. doi: 10.1161/CIRCULATIONAHA.107.707661. Epub 2008 Jan 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.