Prenatal DiagnosisNCT04265352
Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe Medical Center
An observational study of Prenatal Diagnosis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. Reviewing the data collected until now may reduce the need for poist natal echography. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Prenatal Diagnosis
- What is being tested?
- No intervension
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborn infants at hillle Yaffe medical center during 10 years: 2010-2019
Who may be able to join
- Newborns who had a cardiac echogenic focus during prenatal pollow-up.
Who cannot join
- Newborns who did not had postnatal echocardiography due to technical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe
Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. Reviewing the data collected until now may reduce the need for poist natal echography.
Read the detailed description
Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. The investigator will review all echographies performed in the last ten years. Reviewing the data collected until now may reduce the need for poist natal echography.
- Conditions
- Prenatal Diagnosis
- Being tested
- No intervension
- Keywords
- cardiac echogenic focus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervensionOther
There is intervention at all.
| Study group | Role | What they receive |
|---|---|---|
| Prenetal cardiac echogenic focus | Newborn infants who had prenatal cardiac echogenic focus Receives: Other: No intervension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any sonographic cardiac pathologic finding exists
Any sonographic cardiac pathologic finding exists, as defined by the cardiologist who performs the postnatal echocardiography.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal DiagnosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265352
- Sponsor's protocol ID
- 0140-19-HYMC
- Status last verified
- Aug 2021
- First submitted
- 8 Jan 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared
Publications
Shakoor S, Ismail H, Munim S. Intracardiac echogenic focus and fetal outcome - review of cases from a tertiary care centre in Karachi, Pakistan. J Matern Fetal Neonatal Med. 2013 Jan;26(1):2-4. doi: 10.3109/14767058.2012.703724. Epub 2012 Jul 13.
PubMed 22708618
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe
- ClinicalTrials.gov ID
- NCT04265352
- Acronym / sponsor ID
- 0140-19-HYMC
- Conditions
- Prenatal Diagnosis
- Keywords
- cardiac echogenic focus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Feb 2020 (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.
Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. Reviewing the data collected until now may reduce the need for poist natal echography.
Detailed description
Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. The investigator will review all echographies performed in the last ten years. Reviewing the data collected until now may reduce the need for poist natal echography.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prenetal cardiac echogenic focus | – | Other: No intervensionNewborn infants who had prenatal cardiac echogenic focus |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborn infants at hillle Yaffe medical center during 10 years: 2010-2019
Key inclusion criteria (1 listed)
- Newborns who had a cardiac echogenic focus during prenatal pollow-up.
Key exclusion criteria (1 listed)
- Newborns who did not had postnatal echocardiography due to technical reasons.
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 |
|---|---|---|
| No intervensionThere is intervention at all. | Other | Prenetal cardiac echogenic focus |
Primary outcome
Any sonographic cardiac pathologic finding exists
Time frame: 2 weeks
Any sonographic cardiac pathologic finding exists, as defined by the cardiologist who performs the postnatal echocardiography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 22708618Shakoor S, Ismail H, Munim S. Intracardiac echogenic focus and fetal outcome - review of cases from a tertiary care centre in Karachi, Pakistan. J Matern Fetal Neonatal Med. 2013 Jan;26(1):2-4. doi: 10.3109/14767058.2012.703724. Epub 2012 Jul 13.
- Individual participant dataSharing planned: No. Will not be shared
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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.
Erez Nadir, MD principal investigator
Hillel Yaffe Medical Center
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 Prenatal Diagnosis, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Aug 2021. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any sonographic cardiac pathologic finding exists (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265352, which also lists 1 linked publication.
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 17 Aug 2021.