Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05601375
Status:
RECRUITING
Last Update Posted:
2022-11-01
First Post:
2022-10-27
Brief Title:
Speckle Tracking Echocardiography in Infants Prenatally and Postnatally
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Comparison of Prenatal and Postnatal Cardiac Function Assessed by Echocardiography Between FoetusesNeonates With a Structural Heart Disease With an Fetal Growth Restriction FGR and Healthy FetusesNeonates
Status:
RECRUITING
Status Verified Date:
2022-10
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:
STIPP
Brief Summary:
Comparison of prenatal and postnatal cardiac function assessed by echocardiography using pulsed wave Doppler Tissue Doppler and speckle tracking strain and strain rate between foetusesneonates with a structural heart disease with an fetal growth restriction FGR and healthy fetusesneonates
Detailed Description:
Rationale
Currently fetal echocardiography mainly focusses on the detection of structural heart disease New echocardiographic techniques also permit detailed assessment of the myocardial contraction and relaxation permitting early detection of subtle changes in heart function Structural heart disease and fetal growth restriction are often accompanied by changes in myocardial function These changes already start during early intrauterine life They can influence clinical course and outcome during fetal adaptation to hypoxic intrauterine conditions during transition from fetal to neonatal circulation and during early neonatal life in both growth restricted infants and infants with heart disease With improved survival of these infants it becomes clear that these changes in cardiac function subtle in early life often progress or induce remodelling affecting long term cardiovascular outcome Expanding the ultrasonic examination of the heart by adding measurements related to fetal cardiac function would increase knowledge about the physiology and pathophysiology of cardiac adaptation during fetal and early neonatal life in healthy infants as well in infants with fetal growth restriction andor a structural heart disease Early detection of dysfunction could lead to targeted preventive strategies to improve short term and long term cardiovascular outcomes in these vulnerable children
Early changes before overt cardiac dysfunction can be observed by analysing myocardial deformation during contraction and relaxation with ultrasonic techniques such as speckletracking focussing on myocardial strain and strain rate and Tissue Doppler These techniques are validated in the adult and pediatric populations but remain experimental in fetuses The fetal heart is much smaller beats faster and is more difficult to assess through the maternal abdomen Besides that the circulation and balance between left and right ventricle is fundamentally different in a fetus This brings challenges in technical feasibility as well as in clinical interpretation of differences Recent technical innovations permit to overcome the former and gain experience with the latter
Along with 2-D 3-D and pulsed waved Doppler assessments inclusion of these techniques could be of additional value in the assessment of the fetal heart
Objective Comparison cardiac function assessed by echocardiography using 2-D 3-D pulsed wave Doppler Tissue Doppler and speckle tracking strain and strain rate between fetusesneonates with structural heart disease fetusesneonates with fetal growth restriction FGR and healthy fetusesneonates both prenatally and postnatally
Study design A longitudinal prospective cohort study conducted at the Department of Obstetrics and Gynaecology Division of Fetal Medicine and the Department of Paediatrics Division of Paediatric Cardiology and Division of Neonatology of the Erasmus Medical Centre Rotterdam
Study population Women aged 16 years with a singleton pregnancy with either a healthy fetus a fetus with an fetal growth restriction or a fetus with structural heart disease
Main study parametersendpoints
Comparison of fetal systolic and diastolic function in fetuses with a structural heart disease fetuses with an FGR and healthy fetuses using speckle tracking pulsed waved Doppler and tissue Doppler at multiple time points in the pregnancy and within 72 hours postpartum
Nature and extent of the burden and risks associated with participation benefit and group relatedness Burden associated with participation exists for the group with healthy fetuses of two additional prenatal investigations and one additional postnatal investigation For the group with fetuses with a structural heart disease the burden exists of one additional prenatal investigation and for the group of fetuses with a growth restriction the burden exists of one additional postnatal investigation All investigations have an estimated time of 15-30 minutes Ultrasound can be safely used in pregnancy Doppler ultrasound can be safely used from 11 weeks in pregnancy There is no risk associated with participation for mother and fetus There is no individual benefit for participants
Currently fetal echocardiography mainly focusses on the detection of structural heart disease New echocardiographic techniques also permit detailed assessment of the myocardial contraction and relaxation permitting early detection of subtle changes in heart function Structural heart disease and fetal growth restriction are often accompanied by changes in myocardial function These changes already start during early intrauterine life They can influence clinical course and outcome during fetal adaptation to hypoxic intrauterine conditions during transition from fetal to neonatal circulation and during early neonatal life in both growth restricted infants and infants with heart disease With improved survival of these infants it becomes clear that these changes in cardiac function subtle in early life often progress or induce remodelling affecting long term cardiovascular outcome Expanding the ultrasonic examination of the heart by adding measurements related to fetal cardiac function would increase knowledge about the physiology and pathophysiology of cardiac adaptation during fetal and early neonatal life in healthy infants as well in infants with fetal growth restriction andor a structural heart disease Early detection of dysfunction could lead to targeted preventive strategies to improve short term and long term cardiovascular outcomes in these vulnerable children
Early changes before overt cardiac dysfunction can be observed by analysing myocardial deformation during contraction and relaxation with ultrasonic techniques such as speckletracking focussing on myocardial strain and strain rate and Tissue Doppler These techniques are validated in the adult and pediatric populations but remain experimental in fetuses The fetal heart is much smaller beats faster and is more difficult to assess through the maternal abdomen Besides that the circulation and balance between left and right ventricle is fundamentally different in a fetus This brings challenges in technical feasibility as well as in clinical interpretation of differences Recent technical innovations permit to overcome the former and gain experience with the latter
Along with 2-D 3-D and pulsed waved Doppler assessments inclusion of these techniques could be of additional value in the assessment of the fetal heart
Objective Comparison cardiac function assessed by echocardiography using 2-D 3-D pulsed wave Doppler Tissue Doppler and speckle tracking strain and strain rate between fetusesneonates with structural heart disease fetusesneonates with fetal growth restriction FGR and healthy fetusesneonates both prenatally and postnatally
Study design A longitudinal prospective cohort study conducted at the Department of Obstetrics and Gynaecology Division of Fetal Medicine and the Department of Paediatrics Division of Paediatric Cardiology and Division of Neonatology of the Erasmus Medical Centre Rotterdam
Study population Women aged 16 years with a singleton pregnancy with either a healthy fetus a fetus with an fetal growth restriction or a fetus with structural heart disease
Main study parametersendpoints
Comparison of fetal systolic and diastolic function in fetuses with a structural heart disease fetuses with an FGR and healthy fetuses using speckle tracking pulsed waved Doppler and tissue Doppler at multiple time points in the pregnancy and within 72 hours postpartum
Nature and extent of the burden and risks associated with participation benefit and group relatedness Burden associated with participation exists for the group with healthy fetuses of two additional prenatal investigations and one additional postnatal investigation For the group with fetuses with a structural heart disease the burden exists of one additional prenatal investigation and for the group of fetuses with a growth restriction the burden exists of one additional postnatal investigation All investigations have an estimated time of 15-30 minutes Ultrasound can be safely used in pregnancy Doppler ultrasound can be safely used from 11 weeks in pregnancy There is no risk associated with participation for mother and fetus There is no individual benefit for participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None