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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Children
• Intervention / Treatment: Other: clinical and biological measurements and questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne FRONDAS, Doctor; Phone Number: +33 2 40 08 34 83; Email: anne.frondas@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44600
    • Recruiting
    • Nantes University Hospital
    • Contact: Anne FRONDAS, Doctor; Phone Number: +33 2 40 08 34 83; Email: anne.frondas@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insulin resistance as measured by the Triglyceride-Glucose Index	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): February 2, 2028

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: RC20-0522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No