Dexamethasone + IVIG for Fetal AV Block
Recruiting in Palo Alto (17 mi)
+40 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: NYU Langone Health
Must be taking: Dexamethasone, IVIG
Must not be taking: Fluorinated steroids
Disqualifiers: Multi-fetal pregnancy, Allergic reactions, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial involves pregnant women using a home device to monitor their baby's heart. If they detect any heart issues, they get a quick follow-up test at the hospital. The goal is to catch and treat heart issues early before they become serious.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking more than 20 mg of prednisone daily or any dose of fluorinated steroids.
What data supports the effectiveness of the drug Dexamethasone + IVIG for Fetal AV Block?
Research shows that dexamethasone, a drug with anti-inflammatory properties, can enhance the effectiveness of other treatments, such as prolonging the duration of pain relief when combined with local anesthetics. Additionally, intravenous gamma-globulin (IVIG) has been used to prevent complications in other fetal conditions, suggesting potential benefits when combined with dexamethasone.
12345Is the combination of Dexamethasone and IVIG generally safe for humans?
In a study on Kawasaki disease, the combination of Dexamethasone and IVIG was used without any serious side effects reported. Additionally, IVIG is known to have dose-related side effects, but these are generally manageable.
23678How is the drug Dexamethasone + IVIG unique for treating fetal AV block?
The combination of Dexamethasone and IVIG for treating fetal AV block is unique because it combines a steroid (Dexamethasone) known for reducing inflammation and immune responses with IVIG, which provides antibodies to help modulate the immune system. This dual approach may offer a novel way to manage the condition, as there are no standard treatments specifically for fetal AV block.
12349Eligibility Criteria
This trial is for pregnant women over 18 with high levels of anti-Ro antibodies, which are linked to fetal heart block. They must be able to monitor the baby's heart rate at home, send audio texts, live within a 6-hour drive of the cardiology site, and take oral medication. It excludes those with multi-fetal pregnancies or known allergies to the study drugs.Inclusion Criteria
I live within a 6-hour drive of the pediatric cardiology site.
I can have my baby's heart rate and rhythm checked with a Doppler outside of the hospital.
You have a high level of anti-Ro 52 or 60 antibodies in your blood.
+7 more
Exclusion Criteria
I am not taking more than 20 mg of prednisone or any dose of fluorinated steroids currently.
I am a woman currently incarcerated.
The fetus already has a heart condition in the current pregnancy.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Surveillance
Mothers perform fetal heart rate and rhythm monitoring (FHRM) 3 times daily and undergo weekly echocardiograms to detect 2° AVB.
up to 25 weeks
3 daily self-monitoring sessions, weekly in-person visits
Treatment
Rapid treatment of 2° AVB identified by FHRM and confirmed by echocardiogram, aiming to reverse 2° AVB before it becomes permanent.
Immediate upon detection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of AV interval and extra-nodal cardiac disease.
up to 1 year post-birth
Regular follow-up visits
Participant Groups
The STOP BLOQ trial tests if early detection and treatment can prevent severe fetal atrioventricular block in babies whose mothers have specific autoantibodies. It involves risk assessment, home monitoring by mothers, and rapid treatment with Dexamethasone or IVIG upon detecting abnormalities.
1Treatment groups
Experimental Treatment
Group I: Mothers with Fetuses Who Have 2° AVB or AV interval > 170msExperimental Treatment2 Interventions
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Dexamethasone for:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
🇺🇸 Approved in United States as Dexamethasone for:
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
🇨🇦 Approved in Canada as Dexamethasone for:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
🇯🇵 Approved in Japan as Dexamethasone for:
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityPalo Alto, CA
West Virginia UniversityMorgantown, WV
Rush University Children's HospitalChicago, IL
Johns Hopkins Children's CenterBaltimore, MD
More Trial Locations
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
References
A Multicenter Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block. [2019]This multicenter, randomized trial compared intravenous (IV) and perineural (PN) dexamethasone for ultrasound (US)-guided infraclavicular brachial plexus block. Our research hypothesis was both modalities would result in similar durations of motor block.
Antenatal management of alloimmune thrombocytopenia with intravenous gamma-globulin: a randomized trial of the addition of low-dose steroid to intravenous gamma-globulin. [2019]Our purposes were to investigate maternal infusions of intravenous gamma-globulin, to prevent intracranial hemorrhage, and to determine whether 1.5 mg dexamethasone and 60 mg prednisone per day add to the effect of intravenous gamma-globulin.
Adverse neonatal outcomes associated with antenatal dexamethasone versus antenatal betamethasone. [2022]Antenatal dexamethasone and betamethasone may not be equally efficacious in the prevention of adverse neonatal outcomes. We compared the risks of periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), and neonatal death among very low birth weight infants who were exposed to dexamethasone, betamethasone, or neither steroid.
Effects of low dose dexamethasone treatment on basal cardiovascular and endocrine function in fetal sheep during late gestation. [2019]This study investigated the effects on ovine fetal basal cardiovascular and endocrine functions of fetal intravenous dexamethasone treatment, resulting in circulating concentrations that were one-fifth of the values measured clinically in human infants following maternal antenatal glucocorticoid therapy. Between 117-120 days gestation (dGA; term: ca 145 dGA), 26 Welsh Mountain sheep fetuses were surgically prepared under general anaesthesia with vascular catheters and a Transonic flow probe positioned around a femoral artery. At 125 +/- 1 dGA, fetuses were infused with dexamethasone (2.06 +/- 0.13 microg kg(-1) h(-1) i.v.; n = 13) or saline (n = 13) for 48 h. Daily fetal arterial blood samples were taken and cardiovascular data were recorded continuously (data acquisition system). Pressor, vasoconstrictor and chronotropic responses to exogenously administered doses of phenylephrine, angiotensin II and arginine vasopressin (AVP) were determined at 124 +/- 1 (pre-infusion), 126 +/- 1 (during infusion) and 128 +/- 1 (post-infusion) dGA. Fetal cardiac baroreflex curves were constructed using peak pressor and heart rate responses to phenylephrine. Dexamethasone treatment elevated fetal mean arterial blood pressure by 8.1 +/- 1.0 mmHg (P
Dexamethasone added to levobupivacaine in ultrasound-guided tranversus abdominis plain block increased the duration of postoperative analgesia after caesarean section: a randomized, double blind, controlled trial. [2022]When added to local anaesthetics, dexamethasone can prolong the duration of peripheral blocks. Dexamethasone has a long and efficient glucocorticoid structure and presents anti-inflammatory properties. The aim of this study was to determine the effect of dexamethasone on the block duration added to levobupivacaine used for transversus abdominis block (TAP) applied to patients who underwent caesarean section.
Efficacy of intravenous immune globulin therapy combined with dexamethasone for the initial treatment of acute Kawasaki disease. [2018]We studied the effects of a new regimen consisting of intravenous immune globulin (IVIG) combined with dexamethasone (DEX) on clinical outcome and serum levels of vascular endothelial growth factor (VEGF) in the initial treatment of Kawasaki disease (KD). A total of 46 KD patients received 0.3 mg/kg per day DEX plus heparin i.v. for 3 consecutive days, together with 2 g/kg IVIG over 4 to 5 days (DEX group). Low-dose acetylsalicylic acid was started after completion of DEX therapy. The control group consisted of 46 KD patients retrospectively treated earlier with 2 g/kg IVIG over 4 to 5 days plus higher dose acetylsalicylic acid (CONTROL group). No serious adverse effect was noted in either group. There were no differences in baseline and post-treatment laboratory data except for C-reactive protein between the groups. Post-treatment C-reactive protein in the DEX group (median 0.9 mg/dl, range 0.0 to 24.7 mg/dl) was lower than that (1.2 mg/dl, range 0.2 to 19.5 mg/dl) in the CONTROL group ( P=0.033 by Mann-Whitney U test). In addition, the mean duration of fever after the first IVIG infusion was 2.2 days (median 1 day, range 1 to 12 days) in the DEX group and 2.8 days (2 days, 1 to 16 days) in the CONTROL group ( P=0.015 by Mann-Whitney U test). The new regimen did not reduce VEGF levels. Two patients in each group developed small- or medium-sized coronary artery aneurysms.
A prospective study of the immediate and delayed adverse events following intravenous immunoglobulin infusions. [2022]To document the incidence of immediate and delayed adverse events (AE) following intravenous immunoglobulin (IVIG) infusion in children.
Lower-dose intravenous immunoglobulins for the treatment of fetal and neonatal alloimmune thrombocytopenia: a cohort study. [2018]Intravenous immunoglobulins (IVIGs) are the cornerstone in the treatment of pregnancies at risk for fetal and neonatal alloimmune thrombocytopenia (FNAIT). The most commonly used dose is 1.0 g/kg/week, not based on any dose-finding study. IVIG is an expensive multidonor human blood product with dose-related side effects. Our aim was to describe the amount of severe thrombocytopenia according to two different doses of IVIG.
Efficacy of two regimens of dexamethasone for Management of preterm labour: pilot study. [2019]Dexamethasone is widely used for prevention of respiratory distress syndrome (RDS), necrotising enterocolitis (NEC) and intra-ventricular haemorrhage (IVH) in preterm babies; decreasing the neonatal mortality rate. There is no consensus on the dose of corticosteroid administered to the mother expected to have a preterm baby. This study is conducted to compare the effectiveness of two popular regimens of dexamethasone administration in decreasing incidence of RDS, necrotizing enterocolitis, IVH and neonatal mortality rate.