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

Preterm Children Clinical Trial

— INFANTPOD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945369
• Other study ID #: RC20-0522
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: February 2, 2028

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: Anne FRONDAS, Doctor
• Phone: +33 2 40 08 34 83
• Email: anne.frondas[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: February 2, 2028
• Est. primary completion date: February 2, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Children

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance as measured by the Triglyceride-Glucose Index		1 day
Secondary	Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index		1 day
Secondary	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
Secondary	creatinine clearance		1 day
Secondary	Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire		1 day
Secondary	Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant"		1 day