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临床试验/NCT06921330
NCT06921330已完成不适用

The Effect of White Cover and Massage Application on Bilirubin Levels and Duration of Phototherapy in Newborns With ABO Incompatibility Receiving Phototherapy

Karabuk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11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
Change in bilirubin level

研究概览

简要总结

This study aims to examine the effect of white cover and massage application on bilirubin levels and phototherapy duration in newborns with ABO incompatibility 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 observed in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiologic and disappears within a few days. If jaundice becomes severe and pathologic hyperbilirubinemia occurs, it can lead to kernicterus (bilirubin accumulation in parts of the brain) or death.Therefore, any infant with hyperbilirubinemia with elevated serum bilirubin levels requires serious attention and treatment.

ABO incompatibility is a cause of indirect hyperbilirubinemia leading to pathologic jaundice. Newborns with ABO incompatibility tend to have higher bilirubin levels due to impaired bilirubin excretion during the neonatal period. ABO incompatibility is observed in approximately 25% of mother-infant pairs. ABO incompatibility may develop when the mother's blood type is O and the baby's blood type is A or B. In ABO incompatibility, maternal anti-A or anti-B antibodies cross the placenta and bind to A/B antigens on the surface of fetal erythrocytes. Antibody-coated erythrocytes are destroyed in the reticuloendothelial system. Bilirubin increases as a result of heme catabolism that is released with the destruction of erythrocytes, and this is reflected in the clinic as neonatal jaundice. In the presence of ABO incompatibility, early screening and close follow-up of newborns in terms of development of hyperbilirubinemia is very important. Traditional treatment modalities for jaundice due to ABO incompatibility are phototherapy and exchange transfusion.

The primary treatment of neonatal jaundice is phototherapy. The efficacy of phototherapy depends on the phototherapy light source, light intensity, the distance between the phototherapy light and the newborn, and the body surface area exposed to light. Phototherapy has potential side effects such as hyperthermia, dehydration, diarrhea, bronze baby syndrome and skin burns in newborns. Therefore, 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 reflective material can be added to the phototherapy. White fabric that can be used as a reflector can reflect the scattered phototherapy light. When fabrics made of reflective materials are hung on the phototherapy device, they can capture light that may be scattered from the baby to the environment and reflect the light back to the baby. The white fabric can increase the irradiance and thus increase bilirubin conversion. Bilirubin is excreted from the body through feces. Removal of bilirubin from the body reduces jaundice. Massage decreases 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
是

入选标准

  • •Abo-Incompatibility term babies with a 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

intervention group

Experimental
  1. During phototherapy, the phototherapy devices of term newborns with abo incompatibility will be covered with white cover.
  2. During phototherapy, infant massage including facial massage, chest massage, arm massage, abdominal massage and leg massage will be applied to term newborns twice a day for 15 minutes each session with an interval of 6 hours.

干预措施: white cover-newborn massage (Other)

control group

No Intervention

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

结局指标

主要结局

Change in bilirubin level

时间窗: From immediately before initiation of phototherapy to immediately after termination of phototherapy

Capillary bilirubin levels will be measured immediately before the initiation of phototherapy and immediately after the termination of phototherapy. The change in capillary bilirubin levels will be calculated and reported.The unit of measure for bilirubin levels will be milligrams per deciliter (mg/dL).

Duration of phototherapy

时间窗: From initiation to termination of phototherapy

The total duration of phototherapy required until bilirubin levels decreased below the treatment threshold will be recorded.The unit of measure for the duration of phototherapy is hours.

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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