Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
- Conditions
- Preterm Children
- Interventions
- Other: clinical and biological measurements and questionnaires
- Registration Number
- NCT04945369
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood.
It has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass.
It can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood.
Children born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol.
Analysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of physical activity will be performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 114
- Children hospitalised at the Nantes University Hospital in the neonatal period
- With a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol
- Born prematurely (under 35 weeks of amenorrhea)
- Included in the Lift cohort with follow-up up to 7 years
- Aged between 8 and 14 years at inclusion
- Children with an isolated metabolic disease: insulin-dependent diabetes; endocrine disease (Cushing's, hypothyroidism)
- Age of 15 years or more
- with a chromosomal anomaly
- with contraindicating measurement of the BOP-POD: ventilatory support, continuous parenteral feeding, elimination stoma
- Refusal of either parent or child
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Children born prematurely included in the EPIPOD protocol and now in the peripubertal period clinical and biological measurements and questionnaires At inclusion in the INFANTPOD study : * Blood and urinary samples collection for evaluation of insulin resistance and of renal function analysis. * Assessment of body composition by a commercialized device called "BOP-POD" and by impedancemetry * Assessment of pulse wave by a commercialized device called "popmetre" * Questionnaires for analysis of eating behaviour * Assessment of physical activity by a commercialized device called "accelerometer" and by questionnaire.
- Primary Outcome Measures
Name Time Method Insulin resistance as measured by the Triglyceride-Glucose Index 1 day
- Secondary Outcome Measures
Name Time Method Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant" 1 day Body composition (percentage of fat versus fat free mass) by BOP-POD and by impedancemetry (biodyXpert) for assessment of body composition variations between peripubertal period and neonatal period 1 day Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index 1 day creatinine clearance 1 day Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire 1 day
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, France