Speckle TrackingSTIPPNCT05601375
Speckle Tracking Echocardiography in Infants, Prenatally and Postnatally
An observational study of Speckle Tracking and Fetus Fetus, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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 foetuses/neonates with a structural heart disease, with an fetal growth restriction (FGR) and healthy fetuses/neonates. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Speckle Tracking, Fetus Fetus, Neonate
- What is being tested?
- Echocardiography
- How many people
- 201 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Sep 2022to 12 Sep 2025
- How long will I take part?
- 20 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women, aged ≥16 years, with a singleton pregnancy with either a healthy fetus, a fetus with fetal growth restriction (defined as: weight and/or abdominal circumference p<10, or deviating growth (weight and/or abdominal circumference) > 20 percentiles, and Doppler abnormalities in either the umbilical artery, the uterine artery or the medial cerebral artery) or a fetus with a structural heart disease.
Who may be able to join
- Informed consent
- Sufficient command of the Dutch language
- A pregnancy with a fetus with a structural heart disease, or
- A pregnancy with a fetus with an FGR (defined as: weight and/or abdominal circumference p<10, or deviating growth (weight and/or abdominal circumference) > 20 percentiles, and Doppler abnormalities in either the umbilical artery, the uterine artery or the medial cerebral artery), or
- A pregnancy with a healthy fetus (without any major fetal congenital abnormality)
Who cannot join
- Multiple pregnancy
- A pregnancy with known fetal genetic abnormality
- A pregnancy with other major fetal congenital abnormalities
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, 3033 XD
Sarah vd Wildenberg, MD, 0630720695, s.vandenwildenberg@erasmusmc.nl
About this study
Official title: Comparison of Prenatal and Postnatal Cardiac Function Assessed by Echocardiography Between Foetuses/Neonates With a Structural Heart Disease, With an Fetal Growth Restriction (FGR) and Healthy Fetuses/Neonates
Comparison of prenatal and postnatal cardiac function assessed by echocardiography using pulsed wave Doppler, Tissue Doppler and speckle tracking (strain and strain rate) between foetuses/neonates with a structural heart disease, with an fetal growth restriction (FGR) and healthy fetuses/neonates.
Read the 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 and/or 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 fetuses/neonates with structural heart disease, fetuses/neonates with fetal growth restriction (FGR) and healthy fetuses/neonates, 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 parameters/endpoints:
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.
- Conditions
- Speckle Tracking, Fetus Fetus, Neonate, Structural Heart Disease, Fetal Growth Restriction
- Being tested
- Echocardiography
- Medical subject headings
- Fetus-in-Fetu, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Fetal echocardiography (ultrasound)
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy with a healthy fetus | 3 times echocardiography in pregnancy once echocardiography after birth Receives: Other: Echocardiography | |
| Pregnancy with a fetus with a structural heart disease | 3 times echocardiography in pregnancy once echocardiography after birth Receives: Other: Echocardiography | |
| Pregnancy with a fetus with a fetal growth restriction | 3 times echocardiography in pregnancy once echocardiography after birth Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of fetal systolic and diastolic function (strain and strain rate)
Measured: 3 years
Secondary outcomes (1)
Technical feasibility of cardiac function measurements of fetal echocardiography using speckle tracking, pulsed waved Doppler and Tissue Doppler in fetuses with a structural heart disease.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start12 Sep 2022
- Primary completion12 Sep 2025 (estimated)
- Study completion12 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speckle TrackingStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (estimated)
- Target duration
- 20 Weeks
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerome Cornette, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601375
- Sponsor's protocol ID
- NL80033.078.21/STIPP-study
- Acronym
- STIPP
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prenatal and Postnatal Cardiac Function Assessed by Echocardiography Between Foetuses/Neonates With a Structural Heart Disease, With an Fetal Growth Restriction (FGR) and Healthy Fetuses/Neonates
- ClinicalTrials.gov ID
- NCT05601375
- Acronym / sponsor ID
- STIPP / NL80033.078.21/STIPP-study
- Conditions
- Speckle Tracking, Fetus Fetus, Neonate, Structural Heart Disease, Fetal Growth Restriction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 12 Sep 2025 (estimated)
- Study completion
- 12 Sep 2025 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of prenatal and postnatal cardiac function assessed by echocardiography using pulsed wave Doppler, Tissue Doppler and speckle tracking (strain and strain rate) between foetuses/neonates with a structural heart disease, with an fetal growth restriction (FGR) and healthy fetuses/neonates.
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 and/or 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 fetuses/neonates with structural heart disease, fetuses/neonates with fetal growth restriction (FGR) and healthy fetuses/neonates, 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 parameters/endpoints:
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnancy with a healthy fetus | – | Other: Echocardiography3 times echocardiography in pregnancy once echocardiography after birth |
| Pregnancy with a fetus with a structural heart disease | – | Other: Echocardiography3 times echocardiography in pregnancy once echocardiography after birth |
| Pregnancy with a fetus with a fetal growth restriction | – | Other: Echocardiography3 times echocardiography in pregnancy once echocardiography after birth |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women, aged ≥16 years, with a singleton pregnancy with either a healthy fetus, a fetus with fetal growth restriction (defined as: weight and/or abdominal circumference p<10, or deviating growth (weight and/or abdominal circumference) > 20 percentiles, and Doppler abnormalities in either the umbilical artery, the uterine artery or the medial cerebral artery) or a fetus with a structural heart disease.
Key inclusion criteria (5 listed)
- Informed consent
- Sufficient command of the Dutch language
- A pregnancy with a fetus with a structural heart disease, or
- A pregnancy with a fetus with an FGR (defined as: weight and/or abdominal circumference p<10, or deviating growth (weight and/or abdominal circumference) > 20 percentiles, and Doppler abnormalities in either the umbilical artery, the uterine artery or the medial cerebral artery), or
- A pregnancy with a healthy fetus (without any major fetal congenital abnormality)
Key exclusion criteria (3 listed)
- Multiple pregnancy
- A pregnancy with known fetal genetic abnormality
- A pregnancy with other major fetal congenital abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyFetal echocardiography (ultrasound) | Other | Pregnancy with a fetus with a fetal growth restriction, Pregnancy with a fetus with a structural heart disease, Pregnancy with a healthy fetus |
Primary outcome
Comparison of fetal systolic and diastolic function (strain and strain rate)
Time frame: 3 years
1 secondary outcome
Technical feasibility of cardiac function measurements of fetal echocardiography using speckle tracking, pulsed waved Doppler and Tissue Doppler in fetuses with a structural heart disease.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speckle Tracking and Fetus Fetus, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of fetal systolic and diastolic function (strain and strain rate) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.