An observational study in Exosomes, Newborn and Bone Diseases, Metabolic, sponsored by Hunan Children's Hospital. Recruiting at 1 site in China. Open to participants aged 0 Hours to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Hunan Children's Hospital · Observational
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.
487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 107 observational studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Hunan Children's Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Gestational age \< 37 weeks, corrected gestational age \< 44 weeks, there was no history of surgery, blood transfusion, congenital malformation and inherited metabolic diseases.
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Exclusion Criteria:
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。
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。
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.
exosomes
Plasma exosomal digital PCR was used for microRNA validation
Time frame: 6 months of age
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Hunan Children's Hospital