the Difference of Follow-up Methods of Neonatal Jaundice (NJFU)

Guizhou University

Status: Enrolling

Conditions: Neonatal Jaundice

Treatments: Behavioral: control; Behavioral: internet plus model

Study type: Observational

Funder types: Other

Identifiers

NCT06075290

NEO20230802

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 16 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Observation group

Description:

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

Treatment:

Behavioral: internet plus model

control group

Description:

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

Treatment:

Behavioral: control