Neurological Development After Exposition to an Antenatal Nuchal TranslucencyEDENNCT02223936
Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype
A study testing group exposed in people with Neurological Development After Exposition to an Antenatal Nuchal Translucency, run by Hospices Civils de Lyon.
Trial summary
Prospective, multicenter study following for 2 years, 250 children who presented during the first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose pregnancy was normal. Read more about this study
- Who is it for?
- Ages Up to 26 monthsHealthy volunteers can take part
- Conditions the study is for
- Neurological Development After Exposition to an Antenatal Nuchal Translucency
- What is being tested?
- group exposed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Mar 2014
- Phase
- Interventional
- 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 26 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -
- Confirmation of the enlargement of nuchal tranlucency by a sonographer referent OR ultrasound abnormality neck restraint by sonographers referents replay after the initial shots (the notion of transience of the pathology of the neck being allowed) with in all cases:
- gestational age between 11 and SA 13 SA 0 days 6 days or a crown-rump length between 45 and 84 mm
- Thickness of the neck> 95th percentile of the standard set for the crown-rump length according to the team Nicolaides
- ultrasound Clichés meet quality criteria HERMANN (score ≥ 5 at least 2 major criteria).
- normal karyotype or not done
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- Morphological Ultrasound second quarter normal or minor abnormalities
- Consent signed holders of parental authority for monitoring up to 2 years and neurodevelopmental assessment at the end of follow-up
- Affiliate or benefit of a social security scheme.
- Newborn who did not have enlarged nuchal translucency and with normal antenatal ultrasound.
- Matching each child the "nuchal group" on:
- Maternity Birth: matching the child witness in the University Hospital of the same region as motherhood in which the child with nuchal group is born.
- gestational age: the child matched group must belong to the same group of gestational age than neck the child with nuchal group
- ≥ 37 weeks
- ≥ 32 and <37 weeks with a less than 2 SA difference
- Weight:
- if the weight of the child of nuchal group is ≥ 2500g, the weight of the child must also be matched to ≥ 2500g and with a weight difference between the two children ≤ 500g
- If the weight of the child of nuchal group is ≥ 1500g and less than 2500g, the weight of the child must also be matched to ≥ 1500g and less than 2500 g and with a weight difference between the two children ≤ 200g
- Apgar score at 5 minutes: the difference in Apgar score at 5 minutes between the two children should be zero or at most equal to 1
- birth: same according to the following criteria:
- primipara
- Multiparous
- Consent signed holders of parental authority for neurodevelopmental assessment and monitoring at the age of 2 years.
- Children with no 21 trisomy, or other intercurrent disease may be responsible for neurodevelopmental
Who cannot join
- Multiple Pregnancy
- Prematurity less than 32 SA
- Birth weight less than 1500 grams
- Discovery of a chromosomal abnormality on karyotype not made prenatally
- Withdrawal of consent.
- intercurrent Event may be the cause of abnormal psychomotor development: fetal distress cause of hospitalization, prenatal viral infection
About this study
Prospective, multicenter study following for 2 years, 250 children who presented during the first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose pregnancy was normal. Evaluating morbidity, mortality, growth and the neurodevelopment of each group by a Brunet Lezine scale. Evaluating anxiety and depression in parents of those children using a scale.
- Being tested
- group exposed, Control
- Keywords
- nuchal translucency, neurological developpment, anxiety, depression, prenatal diagnosis, normal karyotype
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group exposedOther
Assessment by Brunet Lezine scale
ControlOther
Not exposed group
| Study group | Role | What they receive |
|---|---|---|
| children with Prenatal enlarged nuchal transluce | Other | Not described Receives: Other: group exposed |
| Control | Other | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of developmental quotient below 70 compared to a group control
assessed by the Brunet Lezine test
Measured: Assessment at the age of 2 years + / - 45 days for each patient
Secondary outcomes (4)
comparison of the mean and distribution of developmental quotient between the two arms
assessed by the Brunet Lezine test
Measured: at the age of 2 years + / - 45 days
composite outcome measure : comparison of weight, height and head circumference between the two arms
assessed by measurement
Measured: at 3 months, 1 year and 2 years
The status deceased / living and the date and cause of death if applicable
nterview
Measured: any time after birth and before 2 years + / - 45 days
study differences in score post-traumatic stress, anxiety and depression between parents of the two arms
assessment of the questionnaire of posttraumatic stress and HAD scale by the parents during the consultation of the two-year child
Measured: at the consultation at the age of 2 years + / - 45 days of the children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Development After Exposition to an Antenatal Nuchal TranslucencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel BUFFIN, Dr, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223936
- Sponsor's protocol ID
- 2007-491
- Acronym
- EDEN
- Status last verified
- Jul 2014
- First submitted
- 12 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype
- ClinicalTrials.gov ID
- NCT02223936
- Acronym / sponsor ID
- EDEN / 2007-491
- Keywords
- nuchal translucency, neurological developpment, anxiety, depression, prenatal diagnosis, normal karyotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Aug 2014 (estimated)
- 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.
Prospective, multicenter study following for 2 years, 250 children who presented during the first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose pregnancy was normal. Evaluating morbidity, mortality, growth and the neurodevelopment of each group by a Brunet Lezine scale. Evaluating anxiety and depression in parents of those children using a scale.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with Prenatal enlarged nuchal transluce | Other | Other: group exposed |
| Control | Other | Other: Control |
Who may qualify
- Ages
- Up to 26 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- -
- Confirmation of the enlargement of nuchal tranlucency by a sonographer referent OR ultrasound abnormality neck restraint by sonographers referents replay after the initial shots (the notion of transience of the pathology of the neck being allowed) with in all cases:
- gestational age between 11 and SA 13 SA 0 days 6 days or a crown-rump length between 45 and 84 mm
- Thickness of the neck> 95th percentile of the standard set for the crown-rump length according to the team Nicolaides
- ultrasound Clichés meet quality criteria HERMANN (score ≥ 5 at least 2 major criteria).
Key exclusion criteria (6 listed)
- Multiple Pregnancy
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 |
|---|---|---|
| group exposedAssessment by Brunet Lezine scale | Other | children with Prenatal enlarged nuchal transluce |
| ControlNot exposed group | Other | Control |
Primary outcome
Incidence of developmental quotient below 70 compared to a group control
Time frame: Assessment at the age of 2 years + / - 45 days for each patient
assessed by the Brunet Lezine test
4 secondary outcomes
comparison of the mean and distribution of developmental quotient between the two arms
Time frame: at the age of 2 years + / - 45 days
composite outcome measure : comparison of weight, height and head circumference between the two arms
Time frame: at 3 months, 1 year and 2 years
The status deceased / living and the date and cause of death if applicable
Time frame: any time after birth and before 2 years + / - 45 days
study differences in score post-traumatic stress, anxiety and depression between parents of the two arms
Time frame: at the consultation at the age of 2 years + / - 45 days of the children
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 22 Aug 2014.
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.
Rachel BUFFIN, Dr study director
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
A study testing group exposed in people with Neurological Development After Exposition to an Antenatal Nuchal Translucency, run by Hospices Civils de Lyon.
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 24 inclusion and 6 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 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of developmental quotient below 70 compared to a group control (time frame: Assessment at the age of 2 years + / - 45 days for each patient). 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 22 Aug 2014.