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

Primary Purpose

Hyperbilirubinemia, Neonatal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
end tidal carbon monoxide corrected for ambient carbon monoxide (ETCOc)
Internet Plus technology
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperbilirubinemia, Neonatal focused on measuring End tidal carbon monoxide, Internet Plus, jaundice follow-up management model

Eligibility Criteria

12 Hours - 7 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    innavative modeled strategy

    traditional strategy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    the incidence of acute bilirubin encephalitis
    the number of infants with acute bilirubin encephalitis in each group
    the bilirubin level of readministration for hyperbilirubinemia
    the average bilirubin level of infants, who are readmitted for hyperbilirubinemia

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    April 15, 2022
    Last Updated
    May 3, 2022
    Sponsor
    Women's Hospital School Of Medicine Zhejiang University
    Collaborators
    The Children's Hospital of Zhejiang University School of Medicine, Jiaxing University Affiliated Women and Children Hospital, Ningbo Women & Children's Hospital, Shaoxing Women's and Children's Hospital, Jinhua Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05365984
    Brief Title
    Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications
    Official Title
    Study on the Intelligent Follow-up Management Model of Neonatal Jaundice After Discharge Based on Early Multi-dimensional Indicators and Internet Communications
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Women's Hospital School Of Medicine Zhejiang University
    Collaborators
    The Children's Hospital of Zhejiang University School of Medicine, Jiaxing University Affiliated Women and Children Hospital, Ningbo Women & Children's Hospital, Shaoxing Women's and Children's Hospital, Jinhua Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperbilirubinemia, Neonatal
    Keywords
    End tidal carbon monoxide, Internet Plus, jaundice follow-up management model

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    2500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    innavative modeled strategy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    traditional strategy
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    end tidal carbon monoxide corrected for ambient carbon monoxide (ETCOc)
    Intervention Description
    The measurement of end tidal carbon monoxide corrected for ambient carbon monoxide (ETCOc)is conducted in the process of risk evaluation.
    Intervention Type
    Other
    Intervention Name(s)
    Internet Plus technology
    Intervention Description
    The Internet Plus technology is applied in the process of follow-up management.
    Primary Outcome Measure Information:
    Title
    the incidence of acute bilirubin encephalitis
    Description
    the number of infants with acute bilirubin encephalitis in each group
    Time Frame
    within 2 week after birth
    Title
    the bilirubin level of readministration for hyperbilirubinemia
    Description
    the average bilirubin level of infants, who are readmitted for hyperbilirubinemia
    Time Frame
    within 1 months
    Secondary Outcome Measure Information:
    Title
    the cost for the issue of jaundice follow-up
    Description
    compare the fee for intelligent follow-up with the fee for clinical visiting according to present jaundice follow-up suggestion
    Time Frame
    within 1 month
    Title
    the time for the issue of jaundice follow-up
    Description
    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
    Time Frame
    within 1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Hours
    Maximum Age & Unit of Time
    7 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: gestational age between 35(+0)~41(+6) birth weight ≥ 2500 g ethics approval obtained parental consent obtained Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiajun Zhu, doctor
    Phone
    +86-13858089111
    Email
    jiajunzhu@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiajun Zhu
    Organizational Affiliation
    Women's Hospital School Of Medicine Zhejiang University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27235203
    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.
    Results Reference
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    PubMed Identifier
    28094087
    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.
    Results Reference
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    PubMed Identifier
    25537534
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29856776
    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.
    Results Reference
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    PubMed Identifier
    29532503
    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.
    Results Reference
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    PubMed Identifier
    15231951
    Citation
    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. Erratum In: Pediatrics. 2004 Oct;114(4):1138.
    Results Reference
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    PubMed Identifier
    25537539
    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. No abstract available. Chinese.
    Results Reference
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    PubMed Identifier
    27510872
    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.
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    PubMed Identifier
    30896150
    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.
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    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.
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    Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications

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