Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus
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.
Congenital Heart Block
Atrioventricular Nodal Dysfunction
Drug: Dexamethasone or other corticosteroid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Dexamethasone in Neonatal Lupus Congenital Heart Block; PRIDE (PR Interval and Dexamethasone Evaluation) in Congenital Heart Block|
- Neonatal ventricular heart rate [ Time Frame: Measured over 5 months ] [ Designated as safety issue: Yes ]
- Fractional shortening [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Abnormal fluid collection [ Time Frame: Measured over 5 months ] [ Designated as safety issue: Yes ]
- Change in degree of heart block [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Gestational age (weeks) at birth [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Birth weight [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Cardiothoracic ratio [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- EKG and echocardiogram [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Study Completion Date:||October 2008|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Depending on patient and physician decision, a steroid may be administered during pregnancy.
Drug: Dexamethasone or other corticosteroid
Administered during the third trimester of pregnancy
CHB is an abnormal condition in which the heart beats slowly. This is a disease that is 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007358
|United States, Connecticut|
|Yale University Medical Center|
|New Haven, Connecticut, United States, 06520|
|United States, New Jersey|
|St. Barnabas Medical Center|
|Livingston, New Jersey, United States, 07039|
|United States, New York|
|Hospital for Joint Diseases|
|New York, New York, United States, 10003|
|New York University Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Jill P. Buyon||Hospital for Joint Diseases|