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Clinical Trials/NCT06075290
NCT06075290
Recruiting
Not Applicable

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

Guizhou Provincial People's Hospital3 sites in 1 country1,000 target enrollmentOctober 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Jaundice
Sponsor
Guizhou Provincial People's Hospital
Enrollment
1000
Locations
3
Primary Endpoint
Newborn follow-up rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2023
End Date
May 10, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks;
  • 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;
  • The vital signs are stable and meet the discharge requirements;
  • Agree to participate in this project and sign an informed consent form;
  • Parents have a certain understanding ability to cooperate in this study;

Exclusion Criteria

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

Outcomes

Primary Outcomes

Newborn follow-up rate

Time Frame: 10,01,2023 to 10,01,2024

Number of newborns who completed the follow-up program/total number of follow-up newborns

Incidence of severe hyperbilirubinemia

Time Frame: 10,01,2023 to 10,01,2024

The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group

Secondary Outcomes

  • Incidence rate of acute bilirubin encephalopathy(10,01,2023 to 10,01,2024)
  • Follow-up satisfaction(10,01,2023 to 10,01,2024)
  • Average economic cost of treatment(10,01,2023 to 10,01,2024)
  • Mean bilirubin level at admission(10,01,2023 to 10,01,2024)

Study Sites (3)

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