Jaundice, NeonatalNCT04527536
Research of Diagnostic Value for BMJ Infants
An observational study of Jaundice, Neonatal, run by Shanghai First Maternity and Infant Hospital.
Trial summary
Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus. Which can cause long-term dysfunction in infants. Read more about this study
- Who is it for?
- Ages 4 to 42 days
- Conditions the study is for
- Jaundice, Neonatal
- What is being tested?
- Neonatal hyperbilirubinemia
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 42 days
- All sexes
- Child
Study population: Newborn babies born from research start who diagnosed neonatal hyperbilirubinemia and healthy newborns
Who may be able to join
- All the following conditions must be met
- Term newborns admitted to hospital with "neonatal hyperbilirubinemia"
- Exclusive breastfeeding or mainly breastfeeding
- Exclude perinatal infection, G-6P-D deficiency, homoimmune hemolysis, polycythemia, scalp hematoma, intracranial hemorrhage, cholestasis, hypoglycemia, hypothyroidism, hypothermia, neonatal asphyxia, fetus Pathological jaundice factors such as delayed stool excretion.
Who cannot join
- As long as any one of the following conditions should be excluded
- During the follow-up period, breastfeeding was terminated or the daily milk powder intake exceeded 200 ml.
- Other pathological jaundice was diagnosed during the follow-up period.
- Take probiotics during the sampling period.
- The guardian asked to withdraw from the study halfway.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research of Diagnostic Value of Fecal miRNA and Intestinal Flora in Infants With BMJ
Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus. Which can cause long-term dysfunction in infants. But for a long time, BMJ diagnosis has relied on clinical exclusive methods, lack of objective and reliable laboratory indicators. Which leads to misdiag. This project is a single-center, prospective nested case-control study. It is planned to establish a neonatal BMJ cohort. According to the admission criteria, 100 cases of early-onset BMJ and late-onset BMJ will be completed, and 100 healthy controls collected during the same period. , Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis, and try to find the feasibility and practical value of diagnostic markers for feces in infants with BMJ.
Read the detailed description
This project is a single-center, prospective nested case-control study to investigate feasibility and practical value of diagnostic markers in infants with BMJ.
According to the admission criteria, 100 cases of early-onset BMJ, 100 late-onset BMJ and 100 healthy controls will be selected. Their feces, peripheral venous blood and mothers' breast milk were collected for further testing. Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis.
This study is to find the objective and reliable laboratory indicators to diagnose BMJ.
- Conditions
- Jaundice, Neonatal
- Being tested
- Neonatal hyperbilirubinemia
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal hyperbilirubinemiaDiagnostic test
Neonatal hyperbilirubinemia：The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram.
| Study group | Role | What they receive |
|---|---|---|
| early-set BMJ group | Infants were admitted to our hospital at 4-7 days of age and were followed up to 28 days. Other pathological jaundice factors were excluded.Those who met the criteria were the early-onset BMJ group. Receives: Diagnostic Test: Neonatal hyperbilirubinemia | |
| late-onset BMJ group | Infants were admitted to our hospital after 7 days of age and were followed up to 28-42 days or until the jaundice disappeared. Other pathological jaundice factors were excluded..Those who met the criteria were late-onset BMJ Receives: Diagnostic Test: Neonatal hyperbilirubinemia | |
| healthy control | During the same period, the healthy newborns who were born in the obstetrics department of our hospital. These newborns were mainly breastfed or breastfed, and grew well. They were enrolled at 7-14 days of age and were followed up to 28-42 days without pathological jaundice. Receives: Diagnostic Test: Neonatal hyperbilirubinemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of breast milk exosomes miRNA
Analysis of breast milk exosomes miRNA
Measured: 2021.10.01-2022.09.30
Analysis of newborn feces miRNA and intestinal flora analysis
Analysis of newborn feces miRNA and intestinal flora analysis
Measured: 2021.10.01-2022.09.30
UGT1A1 test in newborn blood
UGT1A1 test in newborn blood
Measured: 2021.10.01-2022.09.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, NeonatalStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Li, Doctorate, Principal investigator, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527536
- Sponsor's protocol ID
- ShanghaiFMIH-2020-084
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Diagnostic Value of Fecal miRNA and Intestinal Flora in Infants With BMJ
- ClinicalTrials.gov ID
- NCT04527536
- Acronym / sponsor ID
- ShanghaiFMIH-2020-084
- Conditions
- Jaundice, Neonatal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 26 Aug 2020 (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.
Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus. Which can cause long-term dysfunction in infants. But for a long time, BMJ diagnosis has relied on clinical exclusive methods, lack of objective and reliable laboratory indicators. Which leads to misdiag. This project is a single-center, prospective nested case-control study. It is planned to establish a neonatal BMJ cohort. According to the admission criteria, 100 cases of early-onset BMJ and late-onset BMJ will be completed, and 100 healthy controls collected during the same period. , Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis, and try to find the feasibility and practical value of diagnostic markers for feces in infants with BMJ.
Detailed description
This project is a single-center, prospective nested case-control study to investigate feasibility and practical value of diagnostic markers in infants with BMJ.
According to the admission criteria, 100 cases of early-onset BMJ, 100 late-onset BMJ and 100 healthy controls will be selected. Their feces, peripheral venous blood and mothers' breast milk were collected for further testing. Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis.
This study is to find the objective and reliable laboratory indicators to diagnose BMJ.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early-set BMJ group | – | Diagnostic Test: Neonatal hyperbilirubinemiaInfants were admitted to our hospital at 4-7 days of age and were followed up to 28 days. Other pathological jaundice factors were excluded.Those who met the criteria were the early-onset BMJ group. |
| late-onset BMJ group | – | Diagnostic Test: Neonatal hyperbilirubinemiaInfants were admitted to our hospital after 7 days of age and were followed up to 28-42 days or until the jaundice disappeared. Other pathological jaundice factors were excluded..Those who met the criteria were late-onset BMJ |
| healthy control | – | Diagnostic Test: Neonatal hyperbilirubinemiaDuring the same period, the healthy newborns who were born in the obstetrics department of our hospital. These newborns were mainly breastfed or breastfed, and grew well. They were enrolled at 7-14 days of age and were followed up to 28-42 days without pathological jaundice. |
Who may qualify
- Ages
- 4 to 42 days
- Sex
- All
- Age groups
- Child
- Study population
- Newborn babies born from research start who diagnosed neonatal hyperbilirubinemia and healthy newborns
Key inclusion criteria (4 listed)
- All the following conditions must be met
Key exclusion criteria (5 listed)
- As long as any one of the following conditions should be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal hyperbilirubinemiaNeonatal hyperbilirubinemia：The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram. | Diagnostic test | early-set BMJ group, healthy control, late-onset BMJ group |
Primary outcome
Analysis of breast milk exosomes miRNA
Time frame: 2021.10.01-2022.09.30
Analysis of breast milk exosomes miRNA
Analysis of newborn feces miRNA and intestinal flora analysis
Time frame: 2021.10.01-2022.09.30
Analysis of newborn feces miRNA and intestinal flora analysis
UGT1A1 test in newborn blood
Time frame: 2021.10.01-2022.09.30
UGT1A1 test in newborn blood
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
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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. This study is not recruiting at the moment.
Jing Li, Doctorate principal investigator
Shanghai First Maternity and Infant Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice, Neonatal, run by Shanghai First Maternity and Infant Hospital.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Li, Doctorate (01861358683669, zzhlq3@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of breast milk exosomes miRNA (time frame: 2021.10.01-2022.09.30). The study lists 3 primary outcomes in all. 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 26 Aug 2020.