Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

Study on the Intelligent Follow-up Management Model of Neonatal Jaundice After Discharge Based on Early Multi-dimensional Indicators and Internet Communications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05365984
• Other study ID #: PRO2021-1366
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Jiajun Zhu, doctor
• Phone: +86-13858089111
• Email: jiajunzhu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

1. gestational age between 35(+0)~41(+6)

2. birth weight = 2500 g

3. ethics approval obtained

4. parental consent obtained

Exclusion Criteria:

1. severe perinatal asphyxia

2. infectious diseases

3. persistent need for respiratory support

4. major congenital malformation

5. inborn errors of metabolism

6. pathological neonatal hyperbilirubinemia due to the defects of red blood cell membrane and erythrocyte enzyme

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice
• Jaundice, Neonatal

Intervention

Diagnostic Test:
• end tidal carbon monoxide corrected for ambient carbon monoxide (ETCOc)
The measurement of end tidal carbon monoxide corrected for ambient carbon monoxide (ETCOc)is conducted in the process of risk evaluation.

Other:
• Internet Plus technology
The Internet Plus technology is applied in the process of follow-up management.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Jiaxing University Affiliated Women and Children Hospital, Jinhua Central Hospital, Ningbo Women and Children's Hospital, Shaoxing Women's and Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine

References & Publications (12)

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. Erratum in: Pediatrics. 2004 Oct;114(4):1138. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Du L. [Prevention and intervention strategies for hyperbilirubinemia induced brain injury]. Zhonghua Er Ke Za Zhi. 2014 Oct;52(10):721-3. Chinese. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Chinese. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of acute bilirubin encephalitis	the number of infants with acute bilirubin encephalitis in each group	within 2 week after birth
Primary	the bilirubin level of readministration for hyperbilirubinemia	the average bilirubin level of infants, who are readmitted for hyperbilirubinemia	within 1 months
Secondary	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
Secondary	the time for the issue of jaundice follow-up	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