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Clinical Trials/NCT04945369
NCT04945369
Recruiting
Not Applicable

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

Nantes University Hospital1 site in 1 country114 target enrollmentFebruary 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Children
Sponsor
Nantes University Hospital
Enrollment
114
Locations
1
Primary Endpoint
Insulin resistance as measured by the Triglyceride-Glucose Index
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2022
End Date
February 2, 2028
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Insulin resistance as measured by the Triglyceride-Glucose Index

Time Frame: 1 day

Secondary Outcomes

  • 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)

Study Sites (1)

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