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

N

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Preterm Children

Treatments

Other: clinical and biological measurements and questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT04945369
RC20_0522

Details and patient eligibility

About

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.

Enrollment

114 estimated patients

Sex

All

Ages

8 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

114 participants in 1 patient group

Children born prematurely included in the EPIPOD protocol and now in the peripubertal period
Experimental group
Description:
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.
Treatment:
Other: clinical and biological measurements and questionnaires

Trial contacts and locations

1

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Central trial contact

Anne FRONDAS, Doctor

Data sourced from clinicaltrials.gov

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