Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Exosomes Newborn Bone Diseases, Metabolic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Less than 32 weeks

The gestational age was less than 32 weeks, there was no history of surgery, blood transfusion, congenital malformation and inherited metabolic diseases. The corrected gestational age of less than 44 weeks。

No interventions assigned to this group

32 to 36+6 weeks

The gestational age was 32-36+6 weeks, there was no history of surgery, blood transfusion, congenital malformation and inherited metabolic diseases. The corrected gestational age of less than 44 weeks。

No interventions assigned to this group

control group

Term infants with a gestational age of 37+0-41+6 weeks, no blood transfusion, no surgery, no congenital malformation, no inherited metabolic diseases, no history of parenteral nutrition, no intestinal diseases. The corrected gestational age of less than 44 weeks.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

0 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes