the Difference of Follow-up Methods of Neonatal Jaundice

NCT ID: NCT06075290

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-10

Study Completion Date

2025-05-10

Brief Summary

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The goal of this observational study is to compare the effectiveness and efficiency for precaution of severe hyperbilirubinemia in neonate by different follow-up methods of neonatal jaundice. There are two kinds of follow-up methods in the investigators clinical practice. The one is internet plus follow-up model, the other is conventional clinic follow-up method. Parents of the participant neonates can choose one by themselves. After parents of the participant signed informed consent, the investigators recorded several information including severe hyperbilirubinemia, length of phototherapy, follow-up times, et al. Then the investigators analysed these data in order to know what kind of follow-up method is better to prevent severe hyperbilirubinemia and more easy to be accepted.

Detailed Description

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Conditions

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Neonatal Jaundice

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation group

Intelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up

internet plus model

Intervention Type BEHAVIORAL

Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up

control group

follow-up by conventional methods ; hospital or community follow-up depending on arrangement

control

Intervention Type BEHAVIORAL

follow-up by conventional methods; hospital or community follow-up depending on arrangement

Interventions

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internet plus model

Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up

Intervention Type BEHAVIORAL

control

follow-up by conventional methods; hospital or community follow-up depending on arrangement

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks;
2. Presence of skin yellowing, percutaneous measurement of jaundice or serum bilirubin concentration less than the phototherapy warning value for the same gestational age and day age group;
3. The vital signs are stable and meet the discharge requirements;
4. Agree to participate in this project and sign an informed consent form;
5. Parents have a certain understanding ability to cooperate in this study;

Exclusion Criteria

1. Direct bilirubin ≥34mmol/L;
2. Increased hepatic enzyme level more than twice of normal value;
3. Those infants who have developed bilirubin encephalopathy or neurological damage due to other reasons before follow-up;
4. Unable to continue follow-up due to other diseases.
Minimum Eligible Age

0 Days

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guizhou Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rong Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Guizhou Provincial People's Hospital

Locations

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People's Hospital of Anshun City Guizhou Province

Anshun, Guizhou, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Guizhou University of Chinese

Guiyang, Guizhou, China

Site Status NOT_YET_RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rong Chen, doctor

Role: CONTACT

18985180888

Facility Contacts

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Lu Guo Linang, Master

Role: primary

13698528760

Yang Yang, Bachelor

Role: primary

Rong Chen, doctor

Role: primary

18985180888

Other Identifiers

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NEO20230802

Identifier Type: -

Identifier Source: org_study_id

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