Skip to content

the Difference of Follow-up Methods of Neonatal Jaundice

Application of Two Different Follow-up Methods for Neonatal Jaundice in the Prevention of Severe Hyperbilirubinemia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06075290
Acronym
NJFU
Enrollment
1000
Registered
2023-10-10
Start date
2023-10-10
Completion date
2025-05-10
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice

Keywords

neonatal jaundice, follow-up, internet plus model, severe hyperbilirubinemia

Brief summary

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.

Interventions

BEHAVIORALinternet plus model

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

BEHAVIORALcontrol

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

Sponsors

Guizhou Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 16 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of severe hyperbilirubinemia10,01,2023 to 10,01,2024The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group
Newborn follow-up rate10,01,2023 to 10,01,2024Number of newborns who completed the follow-up program/total number of follow-up newborns

Secondary

MeasureTime frameDescription
Average economic cost of treatment10,01,2023 to 10,01,2024Treatment and transportation costs and so on
Incidence rate of acute bilirubin encephalopathy10,01,2023 to 10,01,2024Number of infants with acute bilirubin encephalopathy/total number of follow-up newborns
Mean bilirubin level at admission10,01,2023 to 10,01,2024sum total serum bilirubin of hospitalized newborns at admission/Total number of hospitalized newborns
Follow-up satisfaction10,01,2023 to 10,01,2024Parents' comments of participating in the study

Countries

China

Contacts

Primary ContactRong Chen, doctor
chenronggy@foxmail.com18985180888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026