Critical congenital heart disease (CHD) is associated with neurodevelopmental disorders, recognised as the most common long-term morbidity in affected children. In critical CHD, that is, CHD requiring cardiac surgery within the first 3 months of life, 30%–50% of children have lower developmental scores. Therefore, early identification of at-risk infants is crucial, yet there is no scientifically evaluated care programme in France. This study aims to evaluate early neurodevelopmental status in infants with prenatally diagnosed critical CHD and to determine how intrinsic susceptibility, prenatal and postnatal factors are functionally associated with developmental delay in this population.

Caractérisation et Accompagnement des Troubles du neurodéveloppement Associés aux MAlfoRmations cArdiaques coNgénitales (CATAMARAN) is a prospective, multicentre cohort study including 150 fetuses with critical CHD and their parents across eight French tertiary CHD centres. The primary objective will be to estimate the proportion of developmental delay at 6 months using the Bayley Scales of Infant and Toddler Development. Secondary objectives will include exploring potential prenatal, perinatal, perioperative determinants of developmental delay. Data collection will span pregnancy to 6 months of age including clinical assessments, maternal questionnaires (stress and nutrition), multimodal imaging and extensive biobanking (placenta, cord and peripheral blood, stool samples). To explore potential genetic and other multi-omic factors involved in the occurrence of a developmental delay, a case-control analysis will be conducted within the cohort.

Clinical and biological data will be collected through a secure system, with anonymised samples analysed in specialised facilities under collaborative agreements. Data confidentiality, traceability and long-term storage are ensured through controlled access and audit trails. Study results will be published and shared with families and the public through the patient association Petit Coeur de Beurre. This study received approval from a French ethics committee in November 2024 (no. 2024-A00425-42).

NCT06690151.

Infertility affects millions of people globally. The presence of key indicators of infertility and fertility care is critical to monitoring access and utilisation of services as part of universal health coverage. In the area of infertility, it is important to track both clinical and non-clinical outcomes of care. Previous reviews have examined clinical indicators for infertility and fertility care; however, non-clinical indicators have received limited attention. This systematic scoping review aims to map the literature related to the non-clinical indicators of fertility care and their types and dimensions.

This review will adhere to the established reporting guidelines for systematic scoping reviews and has been registered in the PROSPERO database to avoid duplication. A systematic literature search strategy will be developed and adapted to four electronic bibliographic databases (Medline [PubMed], EMBASE [Embase.com], CINAHL [EBSCOhost] and Web of Science [Clarivate]). Supplemental searches will be performed to obtain relevant grey literature from major health research institutes and international organisations. The search will be limited to literature published from 1990 to date. This review will cover all non-clinical interventions relevant to human infertility and fertility care. Two reviewers will independently screen papers and identify relevant studies for inclusion using predetermined criteria and extract data based on a predefined template. Types and dimensions of non-clinical indicators will be identified and a descriptive narrative synthesis will be used to describe the overall landscape. This review is expected to start on 1 June 2026 and conclude by 15 December 2026. A preliminary search strategy has been developed.

As this study is based on a review of publicly available literature, ethical approval is not required. This scoping review will provide a comprehensive overview of the existing non-clinical indicators used to measure, report and monitor infertility and fertility care services. The findings will provide a comprehensive evidence base for developing a set of core indicators to monitor infertility and fertility care that can be adopted globally. Results will be disseminated through peer-reviewed publications, scientific conferences and webinars.

CRD420251177901.