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

NCT05365984 | Unknown DMC

• 1 other identifier: PRO2021-1366
• Study Type: interventional
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hyperbilirubinemia, Neonatal

Keywords

End tidal carbon monoxide; Internet Plus; jaundice follow-up management model

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• the cost for the issue of jaundice follow-up

  within 1 month

• the time for the issue of jaundice follow-up

  within 1 month

Study Arms (2)

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.

Diagnostic Test: end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）; Other: Internet Plus technology

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.

Interventions

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.

innavative modeled strategy

Internet Plus technology OTHER

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

innavative modeled strategy

Eligibility Criteria

• Age: 12 Hours - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestational age between 35(+0)\~41(+6)
• birth weight ≥ 2500 g
• ethics approval obtained
• parental consent obtained

You may not qualify if:

• severe perinatal asphyxia
• infectious diseases
• persistent need for respiratory support
• major congenital malformation
• inborn errors of metabolism
• pathological neonatal hyperbilirubinemia due to the defects of red blood cell membrane and erythrocyte enzyme

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• Jiaxing University Affiliated Women and Children Hospital: collaborator
• Ningbo Women & Children's Hospital: collaborator
• Shaoxing Women's and Children's Hospital: collaborator
• Jinhua Central Hospital: collaborator

Related Publications (12)

• 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.

  PMID: 27235203 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.

  PMID: 28094087 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.

  PMID: 25537534 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.

  PMID: 29856776 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.

  PMID: 29532503 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.

  PMID: 15231951 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.

  PMID: 25537539 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.

  PMID: 27510872 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.

  PMID: 30896150 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.

  PMID: 19822593 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.

  PMID: 32358142 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.

  PMID: 32112336 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Technology

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

• Jiajun Zhu

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajun Zhu, doctor

CONTACT

+86-13858089111; jiajunzhu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 9, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 9, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share