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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Erasmus Medical Center

    Rotterdam, 3033 XD

    Sarah vd Wildenberg, MD, 0630720695, s.vandenwildenberg@erasmusmc.nl

    Recruiting

Other trials in Netherlands

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.

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.

Study groups in NCT05601375
Study groupRoleWhat they receive
Pregnancy with a healthy fetus3 times echocardiography in pregnancy once echocardiography after birth
Receives: Other: Echocardiography
Pregnancy with a fetus with a structural heart disease3 times echocardiography in pregnancy once echocardiography after birth
Receives: Other: Echocardiography
Pregnancy with a fetus with a fetal growth restriction3 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.

  1. Comparison of fetal systolic and diastolic function (strain and strain rate)

    Measured: 3 years

Secondary outcomes (1)
  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.

  1. First posted1 Nov 2022
  2. Study start12 Sep 2022
  3. Primary completion12 Sep 2025 (estimated)
  4. Study completion12 Sep 2025 (estimated)

Resources

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
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

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.

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