Nantes University Hospital
Nantes, 44600, France
Location status: Recruiting
Recruiting
NCT Number: NCT04945369
Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
8 year–14 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
clinical and biological measurements and questionnaires
OtherBlood 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 outcomes
-
Insulin resistance as measured by the Triglyceride-Glucose Index
Time frame: 1 day
Secondary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Registry information
Official study title
Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the "EPIPOD" Protocol : Evaluation of Insulin Resistance
Acronym: INFANTPOD
Important dates
- Study start
- 2022
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jun 30, 2021
- Registry last updated
- Nov 14, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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