Congenital Heart DiseaseNeuro-MomsNCT06711666
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
An observational study of Congenital Heart Disease and Cyanotic Congenital Heart Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in France.
Trial summary
Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Congenital Heart Disease, Cyanotic Congenital Heart Disease, d-Transposition of the Great Arteries
- How many people
- 174 participants
- Where
- 5 sitesFrance
- Study dates
- 27 Jun 2025to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Expecting women diagnosed with a foetal complex congenital heart disease. Fathers or co-parent of prenatally diagnosed children with CHD Children with complex congenital heart disease who require neonatal open-heart surgery.
Who may be able to join
- Co-parent of an expecting woman participating in the study
- Age at least 18 years old
- Social security affiliation in France.
- Inclusion criteria for the child diagnosed with congenital heart disease:
- Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study
- Written consent from both parents
Show all 20Show fewer
- Social security affiliation in France.
- Non-inclusion Criteria for mothers:
- Patient refusal to participate
- Participants (i.e., expecting women) who express a wish for medical termination of pregnancy
- Diagnosis of a complex CHD associated with another foetal comorbidity with a clinically recognized impact on neurodevelopment (e.g., genetic syndromes such as trisomies, poly-malformation syndromes).
- Participants who are not able to understand the instructions and/or complete the self-reports
- Expecting women who currently have a major psychiatric condition (e.g., untreated major depression, severe anxiety disorders, psychotic disorders) with or without treatment, at the time of the cardiology consultation or at the time of the first psychological evaluation. Patients who will be excluded due to these conditions will be referred for perinatal psychiatric consultation.
- Persons under legal or judicial guardianship.
- Non-inclusion Criteria for fathers or co-parents:
- Patient refusal to participate
- Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment
- Persons under legal or judicial guardianship.
- Exclusion Criteria for the mother of a child diagnosed with CHD:
- 1. The child has not undergone surgery within 60 days of birth.
Who cannot join
- 1. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Hopital de Marseille la Timone
Marseille
Beatrice DESNOUS
Beatrice DESNOUS
- Recruiting
CHU de Montpellier
Montpellier
Marie VINCENTI
Marie VINCENTI
- Recruiting
Institut Saint Pierre
Palavas-les-Flots
Sophie GUILLAUMONT
Sophie GUILLAUMONT
- Recruiting
Hopital Necker Enfants Malades
Paris
Johanna CALDERON, johanna.calderon@inserm.fr
Johanna CALDERON
- Recruiting
Hopital Haut Leveque
Pessac
Julie CHABANEIX, julie.chabaneix@chu-bordeaux.fr
Julie CHABANEIX
About this study
Official title: Prenatal Maternal Mental Health and Neurodevelopment in Children With an Antenatal Diagnosis of Congenital Heart Disease: The Neuro-Moms CHD Study
Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.
Read the detailed description
This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes in congenital heart disease. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life (between 12 and 18 months). It will include children with a prenatally diagnosed critical heart defect (i.e., cyanotic types of CHD with the potential to cause rapid hypoxemia after birth) requiring neonatal open-heart surgery (within the first weeks of life).
Expecting mothers who agree to participate will undergo comprehensive psychological evaluations conducted by a licensed mental health professional with defined expertise in perinatal mental health. Fathers or co-parent of the child with foetal CHD will also participate in self-reports during the prenatal period. A total of three time points of psychological assessment will be done: Time 1, during the prenatal period, after 28 weeks of gestation); Time 2, an interim self-report assessment using only questionnaires before post-surgery hospital discharge for the baby (after intensive care transfer to hospitalization); and Time 3, 1 year after the birth of their child. Maternal assessments will include standardized self-report measures of stress, anxiety, depression and other psychological symptoms as well as a clinical interview for Time 1 and 2. Co-parent assessment at Time 1 will include self-reports of overall mental health, anxiety and coping skills.
Infant neurodevelopmental and behavioural assessments will be conducted at year 1 (between 12-18 months for the child) during a joint visit of the dyad mother-child. All assessments will be standardized and have French norms and instructions for parents and the child. These assessments will evaluate areas such as cognition, emerging language, and motor skills (gross and fine motor abilities). Socio-behavioural outcomes will also be evaluated at this time. All infant developmental assessments will be administered by paediatric neuropsychologists.
- Conditions
- Congenital Heart Disease, Cyanotic Congenital Heart Disease, d-Transposition of the Great Arteries, Hypoplastic Left Heart Syndrome
- Keywords
- psychological stress, Maternal prenatal mental health, Neurodevelopment, Cyanotic congenital heart disease, Prenatal diagnosis
- Medical subject headings
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Stress, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80)
Mental Health Self-Report, Higher scores indicate worse outcomes
Measured: Time 1 Prenatal Visit and Time 3 1-year old Visit
Bayley Scales of Infant and Toddler Development (BAYLEY-4) (min score 50- max score 150)
Standardized Neurodevelopmental Assessment, Higher scores better outcome, Mean 100; SD 15
Measured: Time 3 1-year old Visit
Secondary outcomes (5)
State-Trait Anxiety Inventory (STAI-Y) (min score 20 - max score 80)
Anxiety self-report, Higher scores worse outcomes
Measured: Time 1 Prenatal Visit, Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit and Time 3 1-year old Visit
Coping Inventory for Stressful Situations (CISS), (min score 20 - max score 80)
Coping self-report, Higher scores better outcomes
Measured: Time 1 Prenatal Visit and Time 3 1-year old Visit
Post-partum depression Edinburgh Scale (EPDS) (min score 0 - max score 30)
Post-partum depression self-report, Higher scores worse outcomes
Measured: Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit
Post-Traumatic Stress Scale (PCL-5), (min score 0 - max score 80)
Self-report scale on PTSD symptoms, Higher scores worse outcomes
Measured: Time 3 1-year old Visit
Ages and Stages Parent Report, 3rd Edition (min score 0 - max score 60)
Developmental questionnaire for parents, Higher scores worse outcomes
Measured: Time 3 1-year old Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start27 Jun 2025
- Primary completionOct 2028 (estimated)
- Study completionFeb 2029 (estimated)
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 Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- 174 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711666
- Sponsor's protocol ID
- C23-22
- Other IDs
- 2024-A02138-39
- Acronym
- Neuro-Moms
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deninotti J, Derridj N, Martins S, Laux D, Stos B, Levy M, Desnous B, Guillaumont S, Amedro P, Chabaneix J, Pfister M, Marguin G, Desmure G, Vincenti M, Bonnet D, Calderon J. Prenatal maternal mental health and neurodevelopment in congenital heart disease in France: the neuro-moms CHD multicentre prospective study protocol. BMJ Open. 2025 Dec 23;15(12):e104889. doi: 10.1136/bmjopen-2025-104889.
PubMed 41436266
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Maternal Mental Health and Neurodevelopment in Children With an Antenatal Diagnosis of Congenital Heart Disease: The Neuro-Moms CHD Study
- ClinicalTrials.gov ID
- NCT06711666
- Acronym / sponsor ID
- Neuro-Moms / C23-22
- Conditions
- Congenital Heart Disease, Cyanotic Congenital Heart Disease, d-Transposition of the Great Arteries, Hypoplastic Left Heart Syndrome
- Keywords
- psychological stress, Maternal prenatal mental health, Neurodevelopment, Cyanotic congenital heart disease, Prenatal diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 2 Dec 2024 (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.
Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.
Detailed description
This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes in congenital heart disease. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life (between 12 and 18 months). It will include children with a prenatally diagnosed critical heart defect (i.e., cyanotic types of CHD with the potential to cause rapid hypoxemia after birth) requiring neonatal open-heart surgery (within the first weeks of life).
Expecting mothers who agree to participate will undergo comprehensive psychological evaluations conducted by a licensed mental health professional with defined expertise in perinatal mental health. Fathers or co-parent of the child with foetal CHD will also participate in self-reports during the prenatal period. A total of three time points of psychological assessment will be done: Time 1, during the prenatal period, after 28 weeks of gestation); Time 2, an interim self-report assessment using only questionnaires before post-surgery hospital discharge for the baby (after intensive care transfer to hospitalization); and Time 3, 1 year after the birth of their child. Maternal assessments will include standardized self-report measures of stress, anxiety, depression and other psychological symptoms as well as a clinical interview for Time 1 and 2. Co-parent assessment at Time 1 will include self-reports of overall mental health, anxiety and coping skills.
Infant neurodevelopmental and behavioural assessments will be conducted at year 1 (between 12-18 months for the child) during a joint visit of the dyad mother-child. All assessments will be standardized and have French norms and instructions for parents and the child. These assessments will evaluate areas such as cognition, emerging language, and motor skills (gross and fine motor abilities). Socio-behavioural outcomes will also be evaluated at this time. All infant developmental assessments will be administered by paediatric neuropsychologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Expecting women diagnosed with a foetal complex congenital heart disease. Fathers or co-parent of prenatally diagnosed children with CHD Children with complex congenital heart disease who require neonatal open-heart surgery.
Key inclusion criteria (20 listed)
- Co-parent of an expecting woman participating in the study
- Age at least 18 years old
- Social security affiliation in France.
- Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study
- Written consent from both parents
Key exclusion criteria (1 listed)
- 1. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80)
Time frame: Time 1 Prenatal Visit and Time 3 1-year old Visit
Mental Health Self-Report, Higher scores indicate worse outcomes
Bayley Scales of Infant and Toddler Development (BAYLEY-4) (min score 50- max score 150)
Time frame: Time 3 1-year old Visit
Standardized Neurodevelopmental Assessment, Higher scores better outcome, Mean 100; SD 15
5 secondary outcomes
State-Trait Anxiety Inventory (STAI-Y) (min score 20 - max score 80)
Time frame: Time 1 Prenatal Visit, Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit and Time 3 1-year old Visit
Coping Inventory for Stressful Situations (CISS), (min score 20 - max score 80)
Time frame: Time 1 Prenatal Visit and Time 3 1-year old Visit
Post-partum depression Edinburgh Scale (EPDS) (min score 0 - max score 30)
Time frame: Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit
Post-Traumatic Stress Scale (PCL-5), (min score 0 - max score 80)
Time frame: Time 3 1-year old Visit
Ages and Stages Parent Report, 3rd Edition (min score 0 - max score 60)
Time frame: Time 3 1-year old Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Derived from this study: PubMed 41436266Deninotti J, Derridj N, Martins S, Laux D, Stos B, Levy M, Desnous B, Guillaumont S, Amedro P, Chabaneix J, Pfister M, Marguin G, Desmure G, Vincenti M, Bonnet D, Calderon J. Prenatal maternal mental health and neurodevelopment in congenital heart disease in France: the neuro-moms CHD multicentre prospective study protocol. BMJ Open. 2025 Dec 23;15(12):e104889. doi: 10.1136/bmjopen-2025-104889.
- Video Neuro-Moms CHDLink provided by the sponsor.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Cyanotic Congenital Heart Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in France.
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 20 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Calderon, PhD (330603830737, johanna.calderon@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80) (time frame: Time 1 Prenatal Visit and Time 3 1-year old Visit). The study lists 2 primary outcomes in all. 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 NCT06711666, 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 30 Jul 2026.