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

Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the EPIPOD Protocol : Evaluation of Insulin Resistance

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04945369
Acronym
INFANTPOD
Enrollment
114
Registered
2021-06-30
Start date
2022-02-02
Completion date
2028-02-02
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Children

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.

Interventions

OTHERclinical 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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 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

Design outcomes

Primary

MeasureTime frame
Insulin resistance as measured by the Triglyceride-Glucose Index1 day

Secondary

MeasureTime frame
Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index1 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 period1 day
creatinine clearance1 day
Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire1 day
Eating behaviour using standardized french questionnaire named QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant1 day

Countries

France

Contacts

Primary ContactAnne FRONDAS, Doctor
anne.frondas@chu-nantes.fr+33 2 40 08 34 83

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026