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| Name | Class |
|---|---|
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| Jiaxing University Affiliated Women and Children Hospital | UNKNOWN |
| Ningbo Women & Children's Hospital | OTHER |
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In this prospective multi-center randomized clinical trial, a new follow-up strategy for neonatal jaundice after discharge will be evaluated. It is based on current risk factors of neonatal hyperbilirubinemia, added with the rate of bilirubin production (exhaled carbon monoxide measurement) as a new indicator,and incorporated with Internet Plus technology. Traditional methods following the Chinese guideline for neonatal hyperbilirubinemia were applied in the control group. The morbidity of BIND, the number of outpatient follow-up after discharge and the convenience will be compared between the two groups. The accuracy, effectiveness, safety and convenience of the study strategy will be testified.
The eligible newborns will be randomized into two groups: the study group (innovative strategy) and the controlled group (traditional strategy).
The innovative strategy included the ETCOc measurement in the risk evaluating process and the Internet Plus approach in the follow-up process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| innavative modeled strategy | Experimental | In this arm, the risk evaluation before discharge for hyperbilirubenemia needing further intervention is based on Bhutani nomogram and end tidal carbon monoxide corrected for ambient carbon monoxide. Assessment result includes high risk, median risk, low risk and delayed discharge. Internet Plus technology is applied in follow-up management. |
|
| traditional strategy | No Intervention | In this arm, the risk evaluation before discharge for hyperbilirubenemia needing further intervention is based on Bhutani nomogram and the follow-up table advised by the Chinese guideline for neonatal hyperbilirubinemia. Assessment result includes high risk, median risk and low risk. Traditional outpatient is applied in follow-up management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc） | Diagnostic Test | The measurement of end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）is conducted in the process of risk evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of acute bilirubin encephalitis | the number of infants with acute bilirubin encephalitis in each group | within 2 week after birth |
| the bilirubin level of readministration for hyperbilirubinemia | the average bilirubin level of infants, who are readmitted for hyperbilirubinemia | within 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| the cost for the issue of jaundice follow-up | compare the fee for intelligent follow-up with the fee for clinical visiting according to present jaundice follow-up suggestion | within 1 month |
| the time for the issue of jaundice follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiajun Zhu, doctor | Contact | +86-13858089111 | jiajunzhu@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiajun Zhu | Women's Hospital School Of Medicine Zhejiang University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27235203 | Background | Bhutani VK, Wong RJ, Stevenson DK. Hyperbilirubinemia in Preterm Neonates. Clin Perinatol. 2016 Jun;43(2):215-32. doi: 10.1016/j.clp.2016.01.001. Epub 2016 Mar 23. | |
| 28094087 | Background | Cortey A, Renesme L, Raignoux J, Bedu A, Casper C, Tourneux P, Truffert P. [Management of jaundice in the newborn>/=35 GW: From screening to follow-up after discharge. Guidelines for clinical practice]. Arch Pediatr. 2017 Feb;24(2):192-203. doi: 10.1016/j.arcped.2016.11.011. Epub 2017 Jan 14. French. |
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| Shaoxing Women's and Children's Hospital | UNKNOWN |
| Jinhua Central Hospital | OTHER |
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| Internet Plus technology | Other | The Internet Plus technology is applied in the process of follow-up management. |
|
compare the time for intelligent follow-up，including the time for TSB measurement and internet commuication，with the time for clinical visiting according to present jaundice follow-up suggestion
| within 1 month |
| 25537534 | Background | Du L. [Prevention and intervention strategies for hyperbilirubinemia induced brain injury]. Zhonghua Er Ke Za Zhi. 2014 Oct;52(10):721-3. No abstract available. Chinese. |
| 29856776 | Background | Castillo A, Grogan TR, Wegrzyn GH, Ly KV, Walker VP, Calkins KL. Umbilical cord blood bilirubins, gestational age, and maternal race predict neonatal hyperbilirubinemia. PLoS One. 2018 Jun 1;13(6):e0197888. doi: 10.1371/journal.pone.0197888. eCollection 2018. |
| 29532503 | Background | Bhutani VK, Maisels MJ, Schutzman DL, Castillo Cuadrado ME, Aby JL, Bogen DL, Christensen RD, Watchko JF, Wong RJ, Stevenson DK. Identification of risk for neonatal haemolysis. Acta Paediatr. 2018 Aug;107(8):1350-1356. doi: 10.1111/apa.14316. Epub 2018 Apr 16. |
| 15231951 | Background | American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297. |
| 25537539 | Background | Subspecialty Group of Neonatology, The Society of Pediatrics, Chinese Medical Association. [The experts consensus on the management of neonatal hyperbilirubinemia]. Zhonghua Er Ke Za Zhi. 2014 Oct;52(10):745-8. No abstract available. Chinese. |
| 27510872 | Background | Rong ZH, Luo F, Ma LY, Chen L, Wu L, Liu W, Du LZ, Luo XP. [Evaluation of an automatic image-based screening technique for neonatal hyperbilirubinemia]. Zhonghua Er Ke Za Zhi. 2016 Aug;54(8):597-600. doi: 10.3760/cma.j.issn.0578-1310.2016.08.008. Chinese. |
| 30896150 | Background | Tabatabaee RS, Golmohammadi H, Ahmadi SH. Easy Diagnosis of Jaundice: A Smartphone-Based Nanosensor Bioplatform Using Photoluminescent Bacterial Nanopaper for Point-of-Care Diagnosis of Hyperbilirubinemia. ACS Sens. 2019 Apr 26;4(4):1063-1071. doi: 10.1021/acssensors.9b00275. Epub 2019 Mar 29. |
| 19822593 | Background | Dalal SS, Mishra S, Agarwal R, Deorari AK, Paul V. Does measuring the changes in TcB value offer better prediction of Hyperbilirubinemia in healthy neonates? Pediatrics. 2009 Nov;124(5):e851-7. doi: 10.1542/peds.2008-3623. Epub 2009 Oct 12. |
| 32358142 | Background | Ma X, Zhu J, Du L. Neonatal Management During the Coronavirus Disease (COVID-19) Outbreak: The Chinese Experience. Neoreviews. 2020 May;21(5):e293-e297. doi: 10.1542/neo.21-5-e293. No abstract available. |
| 32112336 | Background | Ma XL, Chen Z, Zhu JJ, Shen XX, Wu MY, Shi LP, Du LZ, Fu JF, Shu Q. Management strategies of neonatal jaundice during the coronavirus disease 2019 outbreak. World J Pediatr. 2020 Jun;16(3):247-250. doi: 10.1007/s12519-020-00347-3. Epub 2020 Feb 28. |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013672 | Technology |
| ID | Term |
|---|---|
| D013676 | Technology, Industry, and Agriculture |
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