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

NCT04945369 | Recruiting

• 1 other identifier: RC20_0522
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Children

Outcome Measures

Primary Outcomes (1)

• Insulin resistance as measured by the Triglyceride-Glucose Index

  1 day

Secondary Outcomes (5)

• Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index

  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

• creatinine clearance

  1 day

• Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire

  1 day

• Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant"

  1 day

Study Arms (1)

Children born prematurely included in the EPIPOD protocol and now in the peripubertal period

EXPERIMENTAL

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.

Other: clinical and biological measurements and questionnaires

Interventions

clinical and biological measurements and questionnaires OTHER

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

Children born prematurely included in the EPIPOD protocol and now in the peripubertal period

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44600, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Anne FRONDAS, Doctor

CONTACT

+33 2 40 08 34 83; anne.frondas@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 30, 2021
• Study Start: February 2, 2022
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): February 2, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

FR (1)