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临床试验/NCT04099602
NCT04099602已完成不适用

Investigation of the Effect of Massage on Bilirubin Level in Preterm Infants

Ege University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年4月6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
64
试验地点
2
主要终点
Transcutaneous Bilirubin Levels

研究概览

简要总结

Jaundice (hyperbilirubinemia) which is one of the common causes of repeated hospitalizations in the neonatal period, is a physiological condition seen in 60% of term babies and 80% of premature babies in the first week of life . Premature babies are more susceptible tobilirubin neurotoxicity. Death and severe sequelae due to hyperbilirubinemia can be prevented by early diagnosis and treatment. Massage is one of the applications that can be used to reduce bilirubin levels in newborn infants. Baby massage facilitates bowel movements and bilirubin excretion by reducing enterohepatic circulation. This study was designed as a randomized controlled trial to investigate the effect of massage on bilirubin levels in premature infants.

详细描述

Neonatal jaundice is a physiological condition seen in 60% of infants and 80% of preterm infants in the first week of life. There is no clear data on the frequency of jaundice in newborns in our country. Jaundice is one of the common causes of 75% of hospitalizations in the first week after birth and the recurrence of hospitalizations in the neonatal period. Neonatal jaundice is a non-hazardous and transient condition that can usually resolve spontaneously without treatment. Although it is a transient condition, high bilirubin levels can cause kernicterus which causes severe neurological damage if not diagnosed and treated early .

The severity and complications of hyperbilirubinemia in premature infants are different from term infants. Premature infants are more susceptible to damage caused by serum bilirubin, even at low levels of brain cells. Hyperbilirubinemia in preterm infants is more prevalent, severe, and protracted than that in term infants because of the immaturity of their red blood cells, livers, and gastrointestinal tracts. There also is often a delay in enteral feeds, which may limit intestinal flow and bacterial colonization, resulting in further enhancement of the enterohepatic circulation of bilirubin. Preterm neonates are more susceptible to bilirubin neurotoxicity. Almost all preterm infants less than 35 weeks gestational age have elevated total serum/plasma bilirubin levels, which results in neonatal jaundice, the yellowish discoloration of the skin and conjunctiva caused by bilirubin deposition. The major complication of an elevated total serum (hyperbilirubinemia) is bilirubin-induced neurologic dysfunction (BIND), which occurs when circulating bilirubin crosses the blood-brain barrier and binds to brain tissue . Jaundice is an important problem in newborn infants and death and severe sequelae due to hyperbilirubinemia can be prevented by early diagnosis and treatment. Various treatment methods have been developed to reduce bilirubin levels. The most commonly used methods are; blood exchange, phototherapy and pharmacological agents. Therapeutic interventions prevent BIND and thus kernicterus by lowering the level of bilirubin in the blood. Phototherapy is a common treatment for both treatment and prevention of increased bilirubin levels. Phototherapy has been widely used in the treatment of hyperbilirubinemia of the newborn for more than fifty years. Phototherapy has various side effects, such as damage to the retina and genitalia, loss of body water, skin rashes, watery stools and Bronze Baby Syndrome.

Nowadays, studies on new treatment methods and different applications are being made which support the treatment of jaundice and shorten the length of hospital stay. Kangaroo care reduces the exposure of newborns to phototherapy, swimming, wiping and bathtub bathing have been reported to reduce bilirubin levels. Baby massage is one of the alternative and complementary therapies that can be used to reduce bilirubin levels.

While there are many studies investigating the effect of infant massage on bilirubin levels in term neonates with healthy and hyperbilirubinemia, a limited number of studies investigating the effect of massage on bilirubin levels in premature infants were found.

It is suggested that baby massage can be performed by trained nurses and mothers trained by nurses. Infant massage stimulates defecation by increasing bowel movements, thus decreasing enterohepatic circulation and increasing bilirubin excretion. Bilirubin excretion decreases the speed and severity of hyperbilirubinemia. In some studies investigating the effect of massage on bilirubin levels, transcutaneous bilirubin (TcB) levels or TSB levels were found to be significantly lower, also no significant difference was found in some studies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
32 Weeks 至 38 Months(Child)
性别
All
接受健康志愿者

入选标准

  • families being voluntary to participate in the study
  • infants being born between 32 and 37 weeks plus 6 days of gestation
  • infants having a birth weight of ≥1500 g
  • infants having a fifth-minute Apgar score of more than seven
  • infant's bilirubin level is not sufficient to require phototherapy
  • the vital signs of the baby are within normal limits
  • the absence of congenital major malformation of the infants
  • the lack of patent ductus arteriosus requiring treatment
  • no proven sepsis diagnosis

排除标准

  • neonates with disease disrupting skin integrity (epidermolysis bullosa, ichthyosis, collodion baby)
  • need for phototherapy
  • infants with gastrointestinal obstruction and biliary atresia
  • infants with congenital major deformations

研究组 & 干预措施

Massage group

Experimental

Twice a day after the birth of the baby was massaged by the researcher for 5 days. Bilirubin levels were measured twice daily by the transcutaneous bilirubin meter before the morning massage and 2 hours after the evening massage for 5 days. In the morning (between 07:00-09:00 am) and in the evening (between 19:00-21:00 pm) twice a day, 15-20 minutes baby massage was applied.

干预措施: Baby Massage (Other)

Control group

No Intervention

The control group who were administered standard care and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days

结局指标

主要结局

Transcutaneous Bilirubin Levels

时间窗: "through study completion, an average of 1 year"

bilirubin level mg/dl

次要结局

  • frequency of defecation("through study completion, an average of 1 year")

研究者

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

Gönül Kılıç

Principal Investigator

Ege University

研究点 (2)

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