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Hyperbilirubinemia, NeonatalNCT05365984

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

A study testing end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc） and Internet Plus technology in people with Hyperbilirubinemia, Neonatal, run by Women's Hospital School Of Medicine Zhejiang University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 12 hours to 7 days
Conditions the study is for
Hyperbilirubinemia, Neonatal
What is being tested?
end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc） and Internet Plus technology
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
No sites listed yet
Study dates
May 2022to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 hours to 7 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Jiajun Zhu, doctor contact

+86-13858089111

jiajunzhu@zju.edu.cn

About this study

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

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.

Read the 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.

Being tested
end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）, Internet Plus technology
Keywords
End tidal carbon monoxide, Internet Plus, jaundice follow-up management model
Medical subject headings
Hyperbilirubinemia, Neonatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Internet Plus technologyOther

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

Study groups in NCT05365984
Study groupRoleWhat they receive
innavative modeled strategyExperimentalIn 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.
Receives: Diagnostic Test: end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）; Other: Internet Plus technology
traditional strategyNo interventionIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the incidence of acute bilirubin encephalitis

    the number of infants with acute bilirubin encephalitis in each group

    Measured: within 2 week after birth

  2. the bilirubin level of readministration for hyperbilirubinemia

    the average bilirubin level of infants, who are readmitted for hyperbilirubinemia

    Measured: within 1 months

Secondary outcomes (2)

  1. 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

    Measured: within 1 month

  2. 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

    Measured: within 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study startMay 2022 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365984
Sponsor's protocol ID
PRO2021-1366
Status last verified
Apr 2022
First submitted
15 Apr 2022
Last updated
9 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27235203

  • 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.

    PubMed 28094087

  • 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.

    PubMed 25537534

  • 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.

    PubMed 29856776

  • 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.

    PubMed 29532503

  • 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.

    PubMed 15231951

  • 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.

    PubMed 25537539

  • 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.

    PubMed 27510872

  • 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.

    PubMed 30896150

  • 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.

    PubMed 19822593

  • 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.

    PubMed 32358142

  • 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.

    PubMed 32112336

Questions about this trial

What is this clinical trial studying?

A study testing end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc） and Internet Plus technology in people with Hyperbilirubinemia, Neonatal, run by Women's Hospital School Of Medicine Zhejiang University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiajun Zhu, doctor (+86-13858089111, jiajunzhu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of acute bilirubin encephalitis (time frame: within 2 week after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365984, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.

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