Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: clinical and biological measurements and questionnaires.
- Who it may be relevant to
- Registry conditions: Preterm Children. Basic parameters: 8 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the "EPIPOD" Protocol : Evaluation of Insulin Resistance
Overview
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.
Interventions
- Other clinical and biological measurements and questionnaires
Blood and urinary samples collection for evaluation of insulin resistance and of renal function analysis. Assessment of body composition by BOP-POD and by impedancemetry. Assessment of pulse wave by popmetre. Assessment of physical activity by accelerometer and by questionnaire Questionnaires for analysis of eating behaviour
Primary outcome measures
- Insulin resistance as measured by the Triglyceride-Glucose Index [Time frame: 1 day]
Secondary outcome measures (5)
- Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index [Time frame: 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 [Time frame: 1 day]
- creatinine clearance [Time frame: 1 day]
- Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire [Time frame: 1 day]
- Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant" [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Nantes University Hospital — Nantes
Identifiers
NCT: NCT04945369 · RC20_0522