ExosomesNCT06368154
Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity
An observational study of Exosomes and Newborn, run by Hunan Children's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 0 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Exosomes, Newborn, Bone Diseases, Metabolic
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- The gestational age was 37+0-41+6 weeks and the age was less than 28 days
Who cannot join
- There was no blood transfusion, no operation, no congenital malformation, no inherited metabolic diseases, no history of intravenous nutrition, and no intestinal diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hunan Children's Hospital
Changsha, Hunan, 410007
yinzhi y liu, master, 13467532228, liuyinzhi0837@163.com
About this study
Official title: Prospective Cohort Study of Exosomal microRNAs as Biomarkers for Diagnosis and Therapeutic Efficacy Evaluation of Metabolic Bone Diseases in Premature Infants
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
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
exosomes
Plasma exosomal digital PCR was used for microRNA validation
Measured: 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExosomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368154
- Sponsor's protocol ID
- HCHLL-2019-08
- Status last verified
- Nov 2023
- First submitted
- 11 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Exosomal microRNAs as Biomarkers for Diagnosis and Therapeutic Efficacy Evaluation of Metabolic Bone Diseases in Premature Infants
- ClinicalTrials.gov ID
- NCT06368154
- Acronym / sponsor ID
- HCHLL-2019-08
- Conditions
- Exosomes, Newborn, Bone Diseases, Metabolic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hunan Children's HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- The gestational age was 37+0-41+6 weeks and the age was less than 28 days
Key exclusion criteria (1 listed)
- There was no blood transfusion, no operation, no congenital malformation, no inherited metabolic diseases, no history of intravenous nutrition, and no intestinal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
exosomes
Time frame: 6 months of age
Plasma exosomal digital PCR was used for microRNA validation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exosomes and Newborn, run by Hunan Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yinzhi Y liu, master (13467532228, liuyinzhi0837@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exosomes (time frame: 6 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.