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Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity

Prospective Cohort Study of Exosomal microRNAs as Biomarkers for Diagnosis and Therapeutic Efficacy Evaluation of Metabolic Bone Diseases in Premature Infants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06368154
Enrollment
200
Registered
2024-04-16
Start date
2024-01-01
Completion date
2026-12-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, Metabolic, Exosomes, Newborn

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.

Interventions

None listed

Sponsors

Hunan Children's Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Hours to 72 Hours
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
exosomes6 months of agePlasma exosomal digital PCR was used for microRNA validation

Countries

China

Contacts

Primary Contactyinzhi Y liu, master
liuyinzhi0837@163.com13467532228
Backup Contactrong zhang, master
228965193@qq.com13627422554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026