Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Primary Purpose
Hypoplastic Left Heart Syndrome, Aortic Coarctation, Atrial Septal Aneurysm
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Maternal hyperoxygenation
Sponsored by
About this trial
This is an interventional prevention trial for Hypoplastic Left Heart Syndrome focused on measuring Echocardiography, Congenital Heart Disease, Maternal hyperoxygenation
Eligibility Criteria
Inclusion Criteria:
- All singleton fetuses with CHD at all gestational ages are eligible for enrollment in the study. Patients will be recruited to enroll in the study as they present for clinical care at Fetal Echocardiography clinic. MH assessments will all be performed only at the Beijing Anzhen Hospital. Baseline room air data for CHD may be collected from other referring centers within the Anzhen network.
Exclusion Criteria:
- Non-sinus rhythm, presence of arrhythmia; Fetal hydrops; Severe brain anomaly (which may influence MCA flow); Evidence for significant ventricular dysfunction; Evidence for constriction of the ductus arteriosus
Sites / Locations
- Beijng Anzhen HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Maternal Hyperoxygenation
Arm Description
Maternal hyperoxygenation will be offered by administering 10 liters nasal cannula by face-mask (approximately 60% fiO2) for a minimum of 10 minutes.
Outcomes
Primary Outcome Measures
MCA PI change before and after maternal hyperoxygenation
The response of the MCA PI to maternal hyperoxygenation in various forms of CHD. MCA PI at MH will be compared to baseline at various gestational ages in a variety of types of CHD.
Secondary Outcome Measures
UA PI change before and after maternal hyperoxygenation
Response of the umbilical artery (UA) PI to maternal hyperoxygenation in various forms of CHD. UA PI at MH will be compared to baseline at various gestational ages in a variety of CHD.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03147014
Brief Title
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Official Title
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Detailed Description
The purpose of this study is to investigate the phenomenon of cardiovascular system response to maternal hyperoxygenation in the fetus with congenital heart disease(CHD), which can provide further insight into fetal adaptations to CHD and improve our understanding of the pathophysiology of these conditions.Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography various gestational weeks.The baseline fetal echocardiography parameters has obtained from these gravidas.Then the participants received 10-15 minutes hyperoxygenation, and the accordingly fetal echocardiography parameters were obtained.The objective of the study includes:(1)To investigate the response of the MCA PI to maternal hyperoxygenation in various forms of CHD. Middle cerebral artery(MCA) pulsatility index (PI) at MH will be compared to baseline at various gestational ages in a variety of types of CHD;(2)To investigate the response of the umbilical artery (UA) PI to maternal hyperoxygenation in various forms of CHD. UA PI at MH will be compared to baseline at various gestational ages in a variety of CHD; (3)To study the response of myocardial diastolic function to MH in various forms of CHD. Diastolic inflow patterns across the tricuspid and mitral valves will be measured and ductus venosus flow pattern will be evaluated at MH and compared to baseline at various gestational ages in a variety of CHD;(4)To investigate for any changes in cardiac output and the ratio of flow between the right and left ventricles in response to MH in various forms of CHD;(5)To investigate for changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoplastic Left Heart Syndrome, Aortic Coarctation, Atrial Septal Aneurysm
Keywords
Echocardiography, Congenital Heart Disease, Maternal hyperoxygenation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maternal Hyperoxygenation
Arm Type
Other
Arm Description
Maternal hyperoxygenation will be offered by administering 10 liters nasal cannula by face-mask (approximately 60% fiO2) for a minimum of 10 minutes.
Intervention Type
Biological
Intervention Name(s)
Maternal hyperoxygenation
Intervention Description
approximately 10-15 minutes of maternal hyperoxygenation
Primary Outcome Measure Information:
Title
MCA PI change before and after maternal hyperoxygenation
Description
The response of the MCA PI to maternal hyperoxygenation in various forms of CHD. MCA PI at MH will be compared to baseline at various gestational ages in a variety of types of CHD.
Time Frame
10-15 minutes
Secondary Outcome Measure Information:
Title
UA PI change before and after maternal hyperoxygenation
Description
Response of the umbilical artery (UA) PI to maternal hyperoxygenation in various forms of CHD. UA PI at MH will be compared to baseline at various gestational ages in a variety of CHD.
Time Frame
10-15 minutes
Other Pre-specified Outcome Measures:
Title
Response of myocardial diastolic function to MH in various forms of CHD
Description
Diastolic inflow patterns across the tricuspid and mitral valves will be measured and ductus venosus flow pattern will be evaluated at MH and compared to baseline at various gestational ages in a variety of CHD.
Time Frame
10-15 minutes
Title
Systolic function change before and after MH
Description
any changes in cardiac output and the ratio of flow between the right and left ventricles in response to MH in various forms of CHD.
Time Frame
10-15 minutes
Title
Changes in flow pattern at the aortic isthmus
Description
Changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta
Time Frame
10-15 minutes
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All singleton fetuses with CHD at all gestational ages are eligible for enrollment in the study. Patients will be recruited to enroll in the study as they present for clinical care at Fetal Echocardiography clinic. MH assessments will all be performed only at the Beijing Anzhen Hospital. Baseline room air data for CHD may be collected from other referring centers within the Anzhen network.
Exclusion Criteria:
Non-sinus rhythm, presence of arrhythmia; Fetal hydrops; Severe brain anomaly (which may influence MCA flow); Evidence for significant ventricular dysfunction; Evidence for constriction of the ductus arteriosus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanping Ruan, MD
Phone
+86 15311258732
Email
yanping.ruan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yihua He, MD
Phone
+86 18910778673
Ext
+8618910778673
Email
heyihuaecho@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yihua He, MD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijng Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li, MD
Phone
+86 15901281629
Email
anzhenyuanban@163.com
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
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