NCT04945369 Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
| NCT ID | NCT04945369 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Preterm Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2022-02-02 |
| Primary Completion | 2028-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 114 participants in total. It began in 2022-02-02 with a primary completion date of 2028-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04945369 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 14 Years, studying Preterm Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04945369 currently recruiting?
Yes, NCT04945369 is actively recruiting participants. Contact the research team at anne.frondas@chu-nantes.fr for enrollment information.
Where is the NCT04945369 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT04945369 clinical trial?
NCT04945369 is sponsored by Nantes University Hospital. The trial plans to enroll 114 participants.