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NCT Number: NCT06368154

Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity

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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Key information

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan Children's Hospital

Changsha, Hunan, 410007, China

Location status: Recruiting

Location contact

yinzhi y liu, master

CONTACT

[email protected]

13467532228

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. exosomes

    Time frame: 6 months of age

    Plasma exosomal digital PCR was used for microRNA validation

Study contacts

Contact information is provided by the study sponsor or research team.

rong zhang, master

CONTACT

[email protected]

13627422554

yinzhi Y liu, master

CONTACT

[email protected]

13467532228

Sponsors and collaborators

Lead sponsor

Hunan Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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