The SEV-IDF programme aims to track infants born before 33 weeks of gestation, with very low birth weight (VLBW), neonatal encephalopathy or severe birth anomalies and perinatal disease. It employs an open, prospective, multicentric, population-based cohort approach. This report aims to describe the methodology employed to establish and manage the programme, details regarding follow-up procedures, baseline characteristics of the included infants, and highlights new research opportunities emerging from the "Suivi des Enfants Vulnérables d'Ile-de-France" (SEV-IDF) programme.
The programme aims to (1) detect developmental anomalies early, (2) improve prevention using standardised data, (3) optimise follow-up care and (4) support multidisciplinary research.
Eligible participants are infants alive at discharge from the 59 maternities with a neonatal unit of the Île-de-France (IDF) region (France). A network of 567 trained physicians monitors the children’s development at 4 months, 1 and 2 years of corrected age, and 3, 4, 5, 6 and 7 years of age. Collected data include sociodemographic, pregnancy and neonatal characteristics, and standardised child development scores.
The programme enrolled 21 175 participants between 2016 and 2023, with 16 461 (77.7%) having a gestational age less than 33 weeks, 1916 (9.0%) others having VLBW, 1525 (7.2%) having encephalopathy and 1273 (6.0%) having another severe birth anomaly.
The collected data will enable the SEV-IDF scientific committee to describe high-risk infants in the IDF region, design evidence-based campaigns to improve the quality and effectiveness of the follow-up as well as conduct research on developmental anomalies in these high-risk infants. Ongoing research currently focuses on anticipating loss to follow-up and early detection of developmental anomalies.
Concurrent with infants’ progression in dietary complexity and gut microbiome diversity, infants gradually change their defecation patterns during the first year of life. However, the links between bowel habits, the gut microbiota and early life nutrition remain unclear. The primary outcome is to characterise the gut microbiome development from birth to 1 year of age. Second, to investigate how bowel habits and nutrition in early life relate to the gut microbiome and metabolome during this period of life, and to explore how the development of the gut microbiome associates with host development.
The MOTILITY Mother-Child Cohort (MOTILITY) is a Danish prospective longitudinal cohort study enrolling up to 125 mother–infant dyads. Assessments occur at 36 weeks gestation (visit 1), birth (screening of infant) and 3, 6, 9 and 12 months (±2 weeks) post partum (visits 2–5). At visit 1, maternal anthropometrics, self-collected faecal and urine samples, and questionnaires on bowel habits and lifestyle are obtained. Between visits, infant faecal (biweekly), urine (monthly) and maternal breast milk (monthly until 6 months of age) samples are collected at home, and bowel habits and dietary intake are assessed biweekly by self-reported questionnaires. At visits 2–5, infant blood and saliva samples are collected, and anthropometric measurements are obtained. In addition, dietary intake is recorded thrice throughout the study period for mother and infant, respectively, and infant whole-gut transit time is estimated by sweet corn tests at 9 and 12 months of age. Birth, growth, motor development, sleep patterns, tooth development, overall health and well-being are assessed using questionnaires. Univariate and multivariate statistics will be applied to identify associations between the gut microbiome, early life nutrition and host physiology including bowel habits during the first year of life.
The MOTILITY study has been approved by the Research Ethics Committee for the Capital Region of Denmark (reference number: H-21063016). Selected results will be made available to the participants in the form of a summary document. Results will be published in peer-review journals and by means of national and international conferences.
To investigate the prevalence and risk factors associated with burnout among residents and to explain their experiences with burnout.
Mixed-methods convergent parallel study with an explanatory follow-up.
One tertiary hospital in Mirebalais and one community hospital in Saint-Marc.
Of the 127 registered residents in both settings, 26 were excluded because they were on leave. Therefore, 101 were asked to participate. We received responses from 98 residents (response rate 97.02%).
Data collection took part in two stages: quantitative data collection was first made over a 2-week period in July 2023 using a questionnaire which included the Maslach Burnout Inventory. We simultaneously conducted a qualitative analysis based on three questions around which stress factors were related to work, personal fulfilment and social issues in the questionnaire. Second, following preliminary data results, one focus group was held with the seven chief residents to bring an in-depth understanding of the quantitative data analysis from the study questionnaire.
Sociodemographic and clinical factors linked to burnout for quantitative data. The themes explored for qualitative data were stress factors related to work, personal fulfilment and social issues. One focus group held with the chief residents explained, based on preliminary results, the main causes of burnout among medical residents, influencing factors, coping strategies and perspectives.
Five major findings emerged from the quantitative data, including the following: (a) burnout prevalence was 79.59%; (b) 43% of the residents estimated working more than 80 hours/week; (c) the group with the highest burnout rates were the second-year postgraduate residents (p=0.01); (d) paediatrics and family medicine residents had the highest mean score of emotional exhaustion (p=0.01); (e) general surgery/orthopaedics and paediatrics had the highest mean score of depersonalisation (p
Burnout prevalence was significantly high. The medical education department needs to implement initiatives that improve patient healthcare, boost the residents’ morale and comply with accreditation standards. A cohort study or quality improvement project investigating the impact of interventions might also be suitable, or a study at different times of the academic year and in a less volatile period of time in Haiti might provide a more complete picture of the onset of this syndrome.
Maternal preconception obesity and adverse gestational metabolic health increase the risk of childhood obesity in offspring, but the preconception period may be an opportune time to intervene, given the motivation of the mother and the epigenetic changes that may be beneficial for the gametes during this period. However, there is a lack of studies evaluating children born to women who have had a preconception intervention. Our group has therefore designed an ancillary study to assess children born to women enrolled in the obesity-fertility randomised controlled trial (RCT), who were 6–12 years of age, with the objective of evaluating the effect of a lifestyle intervention delivered during preconception and pregnancy on adiposity and cardiometabolic parameters in the offspring. This manuscript details the study protocol.
This is an ancillary nested cohort study of the obesity-fertility RCT. Women with obesity and infertility were recruited at an academic fertility clinic and randomised to the control group, which followed usual care, or to the intervention group, which received a lifestyle intervention alone for the first 6 months and then in combination with fertility treatments for up to 18 months or until the end of pregnancy. Those who have given birth to a single child are invited to participate in this follow-up study with their child aged 6–12 years. This study started in November 2023 and is expected to end in May 2025. The primary outcome is age-adjusted and sex-adjusted body mass index z-scores in children. Secondary outcomes are anthropometry, body composition, lifestyle, physical fitness level and blood or saliva markers of cardiometabolic health in both mothers and children. Of the 130 women who participated in the obesity-fertility RCT, 52 mother-child dyads (24 in the control group; 28 in the intervention group) were potentially eligible for this follow-up study. Comparisons between groups will be performed using unpaired tests and adjusted for potential confounders using multivariable regression models. This study will provide important new data on the impact of a preconception lifestyle intervention, maintained throughout pregnancy, on the health trajectory of children and mothers 6–12 years after delivery.
The study has been approved by the institutional research ethics review boards of the Centre intégré universitaire de santé et de services sociaux de l’Estrie – Centre hospitalier universitaire de Sherbrooke. The results will be widely disseminated to the scientific community, relevant health professionals and general public.
ClinicalTrials.gov (NCT06402825).