Preterm ChildrenINFANTPODNCT04945369
Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
A study testing clinical and biological measurements and questionnaires in people with Preterm Children, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Preterm Children
- What is being tested?
- clinical and biological measurements and questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2022to 2 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44600
Anne FRONDAS, Doctor, +33 2 40 08 34 83, anne.frondas@chu-nantes.fr
About this study
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
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.
Read more
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
- Being tested
- clinical and biological measurements and questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and biological measurements and questionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: clinical and biological measurements and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance as measured by the Triglyceride-Glucose Index
Measured: 1 day
Secondary outcomes (5)
Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index
Measured: 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
Measured: 1 day
creatinine clearance
Measured: 1 day
Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire
Measured: 1 day
Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant"
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start2 Feb 2022
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm ChildrenStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945369
- Sponsor's protocol ID
- RC20_0522
- Acronym
- INFANTPOD
- Status last verified
- Nov 2025
- First submitted
- 15 Jun 2021
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04945369
- Acronym / sponsor ID
- INFANTPOD / RC20_0522
- Conditions
- Preterm Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children born prematurely included in the EPIPOD protocol and now in the peripubertal period | Experimental | Other: clinical and biological measurements and questionnairesAt 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical and biological measurements and questionnairesBlood 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 | Other | Children born prematurely included in the EPIPOD protocol and now in the peripubertal period |
Primary outcome
Insulin resistance as measured by the Triglyceride-Glucose Index
Time frame: 1 day
5 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical and biological measurements and questionnaires in people with Preterm Children, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne FRONDAS, Doctor (+33 2 40 08 34 83, anne.frondas@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance as measured by the Triglyceride-Glucose Index (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.