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

Primary Purpose

Preterm Children

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

clinical and biological measurements and questionnaires

About this trial

This is an interventional basic science trial for Preterm Children

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nantes University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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 and of neuropsychological development.

Outcomes

Primary Outcome Measures

Insulin resistance as measured by the Triglyceride-Glucose Index

Secondary Outcome Measures

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

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

creatinine clearance

Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire

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

Full Information

NCT ID

NCT04945369

First Posted

June 15, 2021

Last Updated

March 21, 2023

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04945369

Brief Title

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

Acronym

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 and of Neuropsychological Development

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2022 (Actual)

Primary Completion Date

February 2, 2026 (Anticipated)

Study Completion Date

February 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 neuropsychological development will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Children

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

clinical and biological measurements and questionnaires

Intervention Description

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. Questionnaires for analysis of eating behaviour and of neuropsychological development.

Primary Outcome Measure Information:

Title

Insulin resistance as measured by the Triglyceride-Glucose Index

Time Frame

1 day

Secondary Outcome Measure Information:

Title

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

Time Frame

1 day

Title

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

Title

creatinine clearance

Time Frame

1 day

Title

Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire

Time Frame

1 day

Title

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

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne FRONDAS, Doctor

Phone

+33 2 40 08 34 83

anne.frondas@chu-nantes.fr

Facility Information:

Facility Name

Nantes University Hospital

City

Nantes

ZIP/Postal Code

44600

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne FRONDAS, Doctor

Phone

+33 2 40 08 34 83

anne.frondas@chu-nantes.fr

12. IPD Sharing Statement

Learn more about this trial

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

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