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临床试验/NCT07106164
NCT07106164已完成不适用

The Effect of Total Body Massage on Neonatal Jaundice in Preterm Neonates: A Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
stool motions per day

研究概览

简要总结

Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents. However, the remedial practice that has become most common for curing hyperbilirubinemia is phototherapy, has several side-effects. Thus there is constant research going on to find a substitute for phototherapy or to lessen its duration such as total body massage.

详细描述

Neonatal jaundice or hyperbilirubinemia is mostly cured (20% cases) though it can still prove hazardous and need medical intervention The most life-threatening case arising from this condition is kernicterus. Unfortunately, this condition is fatal in 75% cases and 80% of those who stay alive do not escape unscathed and exhibit problems related to the nervous system. Thus a timely cure of neonatal hyperbilirubinemia has become a major preventive measure Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents . However, the most used treatment for curing hyperbilirubinemia is phototherapy, which has several side-effects ranging from doing harm to the cornea and the genital region to causing dehydration, diarrhoea and bronze kid syndrome. Thus there is constant research going on to find a substitute for phototherapy or to lessen the duration of the same.

Infant massage is a traditional practice in several regions of the world, to be more precise, in the cultures of Africa and Asia. A survey done recently in Bangladesh showed that 96% of the caretakers of neonates engaged in massaging the whole body of the infant one to three times a day. Healthcare practitioners in the West have also started to show interest in infant massage, especially, as an interventional measure for infants in neonatal intensive care units (NICUs) where mostly the environment is stressful and lacks adequate tactile stimulation. In order to promote infant growth, more parents and caretakers of low-risk babies are being trained in massage in the Western world studies have showed that massage stimulation encourages the passing of more meconium containing bilirubin by newborns and suggested that neonate massage can contribute toward the prevention of neonatal jaundice and the controlling of bilirubin to within normal range Taking all the above into account, this research was carried out with the aim of studying the effect of massage, using Field's Technique, on neonatal jaundice in preterm newborns on phototherapy.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Hour 至 30 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Preterm neonates from 32 to 36 wks gestational age.
  • •Hyperbilirubinemia needing phototherapy.

排除标准

  • •Serious congenital malformation.
  • •Fetal hydrops.
  • •Hemolytic jaundice.
  • •Confirmed intrauterine infection (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes).
  • •Bilirubin level near exchange transfusion level.
  • •Any skeletal abnormality or joint affection.

研究组 & 干预措施

total body massage

Experimental

patients received total body massage and phototherapy

干预措施: total body massage (Procedure)

total body massage

Experimental

patients received total body massage and phototherapy

干预措施: photo therapy (Device)

control

Active Comparator

neonates received phototherapy only

干预措施: photo therapy (Device)

结局指标

主要结局

stool motions per day

时间窗: baseline and daily throughout study completion, an average of 3 months

Number of times the newborn passes stool will be recorded daily throughout phototherapy and total body massage

bilirubin level

时间窗: baseline and throughout study completion, an average of 3 month

Serum bilirubin recorded on the start of treatment before any massage intervention and regular follow up till discontinuation of phototherapy and rebound level upon stoppage of phototherapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Ibrahim

assistant professor of pediatrics and neonatology , Ain Shams University

Ain Shams University

研究点 (1)

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