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临床试验/NCT06075290
NCT06075290招募中不适用

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

Guizhou Provincial People's Hospital3 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
3
主要终点
Newborn follow-up rate

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 16 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

  • 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.

结局指标

主要结局

Newborn follow-up rate

时间窗: 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

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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