Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity

Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368154
• Other study ID #: HCHLL-2019-08
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Hunan Children's Hospital
• Contact: yinzhi Y liu, master
• Phone: 13467532228
• Email: liuyinzhi0837[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Exosomes
• Metabolic Diseases
• Newborn

Locations

Country	Name	City	State
China	Hunan Children's Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exosomes	Plasma exosomal digital PCR was used for microRNA validation	6 months of age