Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007358
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2000-12-19
Brief Title:
Dexamethasone Treatment for Congenital Heart Block CHB in Newborns With Lupus
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Study of Dexamethasone in Neonatal Lupus Congenital Heart Block PRIDE PR Interval and Dexamethasone Evaluation in Congenital Heart Block
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SSARo and SSBLa 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-RoLa 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
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-RoLa 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-055 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR046265 |
| R01AR046265 | NIH | None | None |