An interventional study of Dexamethasone or other corticosteroid in Congenital Heart Block, Neonatal Lupus and Atrioventricular Nodal Dysfunction, sponsored by NYU Langone Health. Completed at 4 sites in United States. Open to female participants aged 16 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-11.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
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.
72 studies on the registry are indexed under Heart Block; 18 are open to participants now.
This study's planned enrollment of 150 is above the median of 89 across 40 interventional studies indexed under Heart Block.
Browse Heart Block studies →NYU Langone Health is the lead sponsor of 1,390 studies on the registry; 253 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria for Prospective Part of Trial:
Inclusion Criteria for Observational Part of Trial:
Exclusion Criteria for Observational Part of Trial:
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
Neonatal ventricular heart rate
Time frame: Measured over 5 months
Fractional shortening
Time frame: Measured over 5 months
Abnormal fluid collection
Time frame: Measured over 5 months
Change in degree of heart block
Time frame: Measured over 5 months
Gestational age (weeks) at birth
Time frame: Measured over 5 months
Birth weight
Time frame: Measured over 5 months
Cardiothoracic ratio
Time frame: Measured over 5 months
EKG and echocardiogram
Time frame: Measured over 5 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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