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临床试验/NCT05356273
NCT05356273已完成不适用

The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
Bilirubin levels

研究概览

简要总结

Background: It has been reported in the current literature that massage has various positive physiological effects on the newborn. Also baby massage; It increases the collection and excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and tissue fluids. Our aim is to investigate the effect of infant massage on hyperbilirubinemia in newborns receiving phototherapy.

Method: The population of the study consisted of babies who were hospitalized in Istanbul Haseki Training and Research Hospital Neonatal Intensive Care Unit between October 2021 and January 2022 and needed phototherapy. Transcutaneous bilirubin device and data collection form were used to obtain the data. 61 newborns who met the study criteria were randomly divided into experimental (n=30) and control (n=31) groups. Phototherapy was applied to all babies twice a day. In addition to phototherapy, infant massage was applied to the experimental group for 10 minutes just before the phototherapy. Bilirubin level measurements were made 2 hours after the end of phototherapy for both groups. Diaper changes for both groups were carried out 8 times a day, every 3 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Born between 37-42 gestational weeks
  • Birth weight between 2500-4000gr
  • 1st and 5th Apgar score between 7-10
  • Needing phototherapy treatment
  • Diagnosed with indirect hyperbilirubinemia 24 hours or more after birth
  • Orally fed
  • No health problems other than indirect hyperbilirubinemia
  • Newborns who has stable vital signs

排除标准

  • ABO blood incompatibility or Rh incompatibility
  • Diagnosed with direct hyperbilirubinemia
  • Newborns who has skin anomaly
  • Needing fluid replacement
  • Newborns with gastrointestinal disorders

结局指标

主要结局

Bilirubin levels

时间窗: 72 hours

decreasing bilirubin levels within intervention times

次要结局

  • Stool frequency(72 hours)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Dogan

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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