NCT06368154 Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity
| NCT ID | NCT06368154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hunan Children's Hospital |
| Condition | Exosomes |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-01-01 with a primary completion date of 2026-12-31.
⚠ 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
Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs.
Eligibility Criteria
Inclusion Criteria: * The gestational age was 37+0-41+6 weeks and the age was less than 28 days Exclusion Criteria: * There was no blood transfusion, no operation, no congenital malformation, no inherited metabolic diseases, no history of intravenous nutrition, and no intestinal diseases
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06368154 clinical trial?
This trial is open to participants of all sexes, aged 0 Hours or older, up to 72 Hours, studying Exosomes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06368154 currently recruiting?
Yes, NCT06368154 is actively recruiting participants. Contact the research team at liuyinzhi0837@163.com for enrollment information.
Where is the NCT06368154 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06368154 clinical trial?
NCT06368154 is sponsored by Hunan Children's Hospital. The trial plans to enroll 200 participants.