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临床试验/NCT06209489
NCT06209489已完成不适用

The Effect of White Cover and Massage Application on Bilirubin Level and Duration of Phototherapy in Newborns Undergoing Phototherapy

Karabuk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3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
发起方
入组人数
60
试验地点
1
主要终点
Newborn massage

研究概览

简要总结

This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving phototherapy.

详细描述

Hyperbilirubinemia is a common problem seen in the neonatal period, characterized by yellow staining of the skin and sclera, causing an increase in total serum bilirubin >5 mg/dl. Neonatal jaundice is seen in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiological and disappears within a few days. Jaundice may worsen and lead to kernicterus (accumulation of bilirubin in some parts of the brain) or death if pathological hyperbilirubinemia occurs. Therefore, every baby with hyperbilirubinemia and high serum bilirubin levels requires serious attention and treatment. The primary treatment for neonatal jaundice is phototherapy. The effectiveness of phototherapy depends on the phototherapy light source, light intensity, distance between the phototherapy light and the newborn, and the body surface area exposed to the light. Phototherapy has potential side effects in newborns such as hyperthermia, dehydration, diarrhea, bronze baby syndrome, and skin burns. For this reason, the use of phototherapy should be minimized and solutions should be found to shorten the duration of phototherapy. To increase the effectiveness of phototherapy treatment, a reflector material can be added to the phototherapy. White fabric, which can be used as a reflector, can reflect scattered phototherapy light. When fabrics made of reflective materials are hung over the phototherapy device, they can capture the light that may scatter from the baby to the environment and reflect the light back to the baby. White fabric may increase irradiance and therefore lead to increased bilirubin conversion.Studies have reported that massage applied before phototherapy is effective in reducing the bilirubin level in babies with hyperbilirubinemia. Bilirubin is eliminated from the body through defecation. Removing bilirubin from the body reduces jaundice. Massage reduces bilirubin levels by increasing the frequency of bowel movements in newborn babies.

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
Single (Participant)

入排标准

年龄范围
12 Hours 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Term babies with gestational age between 37-42 weeks,
  • Does not have a respiratory, cardiovascular, gastrointestinal or neurological disorder or syndrome that would prevent or complicate oral feeding,
  • Birth weight of 2500 g and above,
  • With phototherapy indication,
  • Do not have any health problems other than neonatal jaundice detected in the prenatal period,
  • Those with a stable health condition,
  • Orally fed,
  • No clinical signs of dehydration,
  • Do not have any skin problems that would prevent baby massage,
  • Newborns with written and verbal informed consent from their families will be included in the study.

排除标准

  • Premature,
  • Those with congenital malformations,
  • Those with hyperbilirubinemia requiring exchange transfusion,
  • Those with Rh hemolytic disease,
  • Having a positive culture test (sepsis),
  • Those with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
  • Birth weight below 2500 grams,
  • Those who were referred to another center during the research,
  • Discharged early,
  • Unexpected complications developed during the research,
  • Bronze child syndrome occurs during phototherapy,
  • Newborns who develop a pathology that will prevent or complicate oral feeding will not be included in the study.

研究组 & 干预措施

Control group

No Intervention

The hospital's clinical routine will be applied to the newborns in the control group.

İntervention group

Experimental
  1. White fabric will be covered over the incubator for term newborns during phototherapy.
  2. During phototherapy, term newborns will receive a baby massage, including facial massage, chest massage, arm massage, abdominal massage and leg massage, twice a day for 15 minutes.

干预措施: White cover (Other)

结局指标

主要结局

Newborn massage

时间窗: 2 times 15 minutes at 12 hour intervals

Baby massage will be applied during phototherapy.

White cover

时间窗: 24 hours

A white cover will be covered over the incubator during phototherapy.

次要结局

未报告次要终点

研究者

发起方
Karabuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep ÇİFTCİ DEMİRTAŞ

Midwife

Karabuk University

研究点 (1)

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