Follow-up of preterm children during their growth years
Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the "EPIPOD" Protocol : Evaluation of Insulin Resistance
This study is trying to see how being born prematurely affects the growth and health of children aged 8 to 14, especially looking at their body fat and risk for insulin resistance as they get older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 8 Years to 14 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT04945369 on ClinicalTrials.gov |
What this trial studies
This study focuses on the long-term health outcomes of children born prematurely, specifically examining their body composition and potential risks for insulin resistance as they grow. Children aged 8 to 14 years, who were previously hospitalized and had body composition measurements taken at discharge, will undergo clinical assessments, biological measurements, and questionnaires to evaluate their health status. The study aims to understand how excessive adiposity in these children may predict future metabolic disturbances.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 14 years who were born prematurely and had body composition measurements taken at discharge from neonatal hospitalization.
Not a fit: Patients who are 15 years or older or have isolated metabolic diseases or chromosomal anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into preventing metabolic disorders in adults who were born prematurely.
How similar studies have performed: Other studies have indicated that monitoring body composition in preterm children can provide valuable insights into their long-term health, suggesting this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes
- Nantes University Hospital — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Anne FRONDAS, Doctor
- Email: anne.frondas@chu-nantes.fr
- Phone: +33 2 40 08 34 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.