Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus
Condition: Congenital Heart Block; Neonatal Lupus; Atrioventricular Nodal Dysfunction; Myocardial Injury
MeSH terms: Heart Block
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dexamethasone or other corticosteroid
Intervention type(s): Drug
Intervention description(s): Administered during the third trimester of pregnancy
Intervention MeSH terms: Dexamethasone
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dexamethasone; Anti-SSA/Ro antibodies; Anti-SSB/La antibodies; Ultrasound; Atrioventricular (AV) nodal dysfunction; Echocardiograms; Mothers