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Clinical Trials in France / NCT04945369
Recruiting Not applicable

Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".

NCT04945369 · tracked via the Priya Life Science France tracker
Sponsor
Nantes University Hospital
Phase
Not applicable
Started
2022-02-02
Last updated
2025-11-14

Condition(s) studied

Preterm Children

Investigational drug(s) / intervention(s)

clinical and biological measurements and questionnaires

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

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
14 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Insulin resistance as measured by the Triglyceride-Glucose Index — 1 day

Trial sites (1)

FacilityCityRegionStatus
Nantes University Hospital Nantes France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04945369 on ClinicalTrials.gov ↗ ← All trials in France