Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity

NCT06368154 | Recruiting

• 1 other identifier: HCHLL-2019-08
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Exosomes; Newborn; Bone Diseases, Metabolic

Outcome Measures

Primary Outcomes (1)

• exosomes

  Plasma exosomal digital PCR was used for microRNA validation

  6 months of age

Study Arms (3)

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。

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。

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.

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Gestational age \< 37 weeks, corrected gestational age \< 44 weeks, there was no history of surgery, blood transfusion, congenital malformation and inherited metabolic diseases.

You may qualify if:

• The gestational age was 37+0-41+6 weeks and the age was less than 28 days

You may not qualify if:

• There was no blood transfusion, no operation, no congenital malformation, no inherited metabolic diseases, no history of intravenous nutrition, and no intestinal diseases

Sponsors & Collaborators

• Hunan Children's Hospital: lead

Study Sites (1)

Hunan Children's Hospital

Changsha, Hunan, 410007, China

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

yinzhi Y liu, master

CONTACT

13467532228; liuyinzhi0837@163.com

rong zhang, master

CONTACT

13627422554; 228965193@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2024

Record last verified: 2023-11

Locations

CN (1)