An observational study in Hyperbilirubinemia, Neonatal, sponsored by Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by Nanjing Medical University · Observational
At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. The study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.
This is a prospective cohort study of healthy term and near-term infants. The mobile network screening and follow-up of neonatal jaundice consists of two parts, one is the screening and follow-up program for healthy neonatal jaundice by using on parents' mobile phones, the other is the online registry of severe hyperbilirubinemia. Firstly，the TCB values of healthy term and near-term infants in delivery institutions will be prospectively recorded and followed up until jaundice subsided by using screening and follow-up program, so as to clarify the natural history of jaundice of healthy newborns in China. Secondly, by establishing an online registry for severe hyperbilirubinemia and "Follow up of jaundice" on Wechat applet, the investigators will find the specific problems of jaundice management in infants with severe hyperbilirubinemia. Lastly, through the follow-up of severe hyperbilirubinemia cases, the investigators will have a better understanding of their prognosis.
96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 300 across 31 observational studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →Nanjing Medical University is the lead sponsor of 171 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the research on the natural history of jaundice via mobile network, the selected population is healthy newborns with gestational age ≥35 weeks and weight ≥2000g, and those without phototherapy or hospital intervention. For the study of the online registry for severe hyperbilirubinemia, the study population is gestational age ≥35 weeks, weight ≥2000g, only hospitalized for jaundice, and the serum total bilirubin reached the threshold of exchange transfusion (≤3 days) or the serum total bilirubin ≥20mg / dl (>3 days).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To record the TCB values of Chinese newborns within 28 days after birth.
Transcutaneous bilirubin (TcB) values will be recorded so as to establish transcutaneous bilirubin nomogram in healthy Chinese term and late-preterm infants at \<28 days of age.
Time frame: 12 months
The comprehensive prognosis of infants
To investigate the comprehensive prognosis of infants with severe hyperbilirubinemia at the corrected age of 2 years in a real-world setting in Jiangsu Province.
Time frame: 60 months
Risk factors of extreme hyperbilirubinemia
Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL.
Time frame: 36 months
The incidence of neurological sequelae.
To assess the clinical outcome at 2 years of corrected age in cases treated with and without exchange transfusion when TSB is at a level of the threshold
Time frame: 60 months
The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.
To calculate the completion rate of each jaundice management measure for severe hyperbilirubinemia cases, whose total serum bilirubin are more than 20mg/dL
Time frame: 36 months
Plan to share: Yes — The study is an open project, and the collected data and information will be provided to all participating centers after review by the data management committee. Anyone interested in this research can contact us directly.
Supporting information: Study protocol
Time frame: The Study Protocol will be shared after the publication until the end of the study.
Access criteria: All participating centres
Started May 2020 (actual). Primary completion is estimated for Apr 2025, 59 months after the start.
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Hyperbilirubinemia, Neonatal →