Hyperbilirubinemia, NeonatalNCT01763632
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
An observational study of Hyperbilirubinemia, Neonatal, run by Nanjing Medical University at 16 sites in China.
Trial summary
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Transcutaneous bilirubinometry
- Type of treatment
- Medical device
- How many people
- 19,601 participants
- Where
- 16 sitesChina
- Study dates
- Jan 2013to Dec 2013
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term or late-preterm newborn infants from thirteen hospital in China were recruited.
Who may be able to join
- Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.
Who cannot join
- All sick newborn infants who were admitted to the intensive care unit.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
The Third Hospital of Peking University
Beijing, 100191
Jinlin Provincial Maternal and Child Health Hospital
Changchun, Jilin, 130021
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Guangdong Maternal and Children's Hospital, Guangzhou Medical College
Guangzhou, Guangdong, 510010
Guiyang Maternal and Child Health Hospital
Guiyang, Guizhou, 550003
The First Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Inner Mongolia Maternal and Child Health Care Hospital
Hohhot, Inner Mongolia, 010020
Guangxi Maternal and Child Health Hospital
Liuzhou, Guangxi, 530003
Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210004
Gynecology and Obstetrics Hospital, Fudan University
Shanghai, 200011
Children's Hospital of Fudan University
Shanghai, 200032
Shaanxi Provincial Maternal and Child Health Hospital
Taiyuan, Shaanxi, 300013
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Shaanxi Provincial Maternal and Child Health Hospital
Xi'an, Shaanxi, 710003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 410100
About this study
Official title: Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram.
The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.
Read the detailed description
Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe hyperbilirubinemia.
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Transcutaneous bilirubinometry
- Keywords
- Hyperbilirubinemia, Neonatal, Transcutaneous Bilirubin
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous bilirubinometryDevice
Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth
During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram.
Measured: Every 12 hr for 168 hr.
Secondary outcomes (1)
Predictive ability of an hour-specific TcB nomogram
Evaluate the rate of rise of bilirubin for different time periods and percentile curves and to assess predictive ability of these percentile curves for hyperbilirubinemia, defined as requirement of phototherapy.
Measured: At the 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 19,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Nanjing Maternity and Child Health Care Hospital, First Affiliated Hospital of Harbin Medical University, Jinlin Provincial Maternal and Child Health Hospital, Peking University Third Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Shanxi Provincial Maternity and Children's Hospital, Obstetrics & Gynecology Hospital of Fudan University, The First Affiliated Hospital of Zhengzhou University, Guangdong Women and Children Hospital, Guangxi Maternal and Child Health Hospital, First Affiliated Hospital of Xinjiang Medical University, Sichuan Provincial People's Hospital, Guiyang Maternity and Child Health Care Hospital
- Responsible party
- Principal investigator, Zhangbin Yu, Nanjing Medical University
- Investigators
- Chao Chen, PhD, Study director, Children's Hospital of Fudan UniversityShuping Han, PhD, Study director, Nanjing Maternity and Child Health Care HospitalZhangbin Yu, PhD, Principal investigator, Nanjing Maternity and Child Health Care HospitalChunming Jiang, PhD, Principal investigator, First Affiliated Hospital of Harbin Medical UniversityYan Gao, PhD, Principal investigator, Jinlin Provincial Maternal and Child Health HospitalXiaomei Tong, PhD, Principal investigator, Peking University Third HospitalMeihua Pu, PhD, Principal investigator, Peking University Third HospitalHongyun Wang, PhD, Principal investigator, Inner Mongolia Maternal and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763632
- Sponsor's protocol ID
- NMU-FY2012-318
- Status last verified
- Oct 2014
- First submitted
- 2 Jan 2013
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China
- ClinicalTrials.gov ID
- NCT01763632
- Acronym / sponsor ID
- NMU-FY2012-318
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, Neonatal, Transcutaneous Bilirubin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,601 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Nanjing Maternity and Child Health Care Hospital, First Affiliated Hospital of Harbin Medical University, Jinlin Provincial Maternal and Child Health Hospital, Peking University Third Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Shanxi Provincial Maternity and Children's Hospital, Obstetrics & Gynecology Hospital of Fudan University, The First Affiliated Hospital of Zhengzhou University, Guangdong Women and Children Hospital, Guangxi Maternal and Child Health Hospital, First Affiliated Hospital of Xinjiang Medical University, Sichuan Provincial People's Hospital, Guiyang Maternity and Child Health Care Hospital
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jan 2013 (estimated)
- 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.
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram.
The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.
Detailed description
Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe hyperbilirubinemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term or late-preterm newborn infants from thirteen hospital in China were recruited.
Key inclusion criteria (1 listed)
- Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.
Key exclusion criteria (1 listed)
- All sick newborn infants who were admitted to the intensive care unit.
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 |
|---|---|---|
| Transcutaneous bilirubinometryDevice: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB) | Device | – |
Primary outcome
Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth
Time frame: Every 12 hr for 168 hr.
During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram.
1 secondary outcome
Predictive ability of an hour-specific TcB nomogram
Time frame: At the 28 days after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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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.
Chao Chen, PhD study director
Children's Hospital of Fudan University
Shuping Han, PhD study director
Nanjing Maternity and Child Health Care Hospital
Zhangbin Yu, PhD principal investigator
Nanjing Maternity and Child Health Care Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal, run by Nanjing Medical University at 16 sites 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: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth (time frame: Every 12 hr for 168 hr.). 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 28 Oct 2014.