跳至主要内容
临床试验/NCT05167474
NCT05167474已完成不适用

Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapy

Eskisehir Osmangazi University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年8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
72
试验地点
2
主要终点
To evaluate the effect of breast milk odor on phototherapy duration during phototherapy treatment.

研究概览

简要总结

ABSTRACT Purpose: This research was done for the purpose of determining the impact of breast milk smell administered to term infants hospitalized in neonatal intensive care units (NICU) due to physiological jaundice on their bilirubin levels, length of remaining in phototherapy and comfort.

Material and Method: It is an experimental, randomisation, controlled research. Target population of the research consisted of a total of 72 term infants who were hospitalized in the NICU of Bilecik Bozuyuk Public Hospital and met the sample selection criteria. Our research includes two groups. Breast milk smell group and control group. The infants were assigned to the groups via randomization method. Sample assignment to the groups was performed using stratification and blocking methods. The infants meeting the research sample selection criteria were stratified according to their postnatal age and then assigned to each group equally (blocking) by lot. However, two infants in the control group were excluded from the research at the request of their parents as the research continued. Thus, the research was completed with a total of 72 infants; 37 in the breast milk smell group and 35 in the control group. In the research, the data were collected using "Personal Data Collection Form", "Phototherapy Follow-up Chart" and "Neonatal Comfort Behavior Scale". The data were analyzed using the SPSS (Statistical Package for Social Sciences) 21.0 (IBM corp. Relased 2012. IBM SPSS Statistics for Windows, version 21.0 Armonk, NY: IBM corp.) package software.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
2 Days 至 5 Days(Child)
性别
All
接受健康志愿者

入选标准

  • The term baby (37-39+6 weeks) of the newborn according to the menstruation of the mothers
  • Need to have phototherapy treatment for the first time
  • Not taking analgesics and/or sedatives in the last 24 hours
  • Body weight in the range of 2500 - 4000 g
  • Postnatal age of the newborn greater than 48 hours
  • Turkish Neonatology Society's approach, follow-up and treatment guideline for neonatal jaundice (2014) Being a medium and high risk baby according to the table of risk status determination of babies according to postnatal age and transcutaneous or total serum bilirubin values.
  • Not taking any treatment or medication other than phototherapy treatment
  • The mother and/or father accepting the study is having a baby.

排除标准

  • Having a health problem other than physiological jaundice
  • Findings such as tachypnea, fever
  • Having an invasive procedure other than blood sampling once a day for babies
  • Exchanged babies
  • Babies with Rh and AB0 incompatibility
  • Babies with elevated bilirubin levels earlier than 48 hours
  • Discord with family

结局指标

主要结局

To evaluate the effect of breast milk odor on phototherapy duration during phototherapy treatment.

时间窗: Upon completion of the study, an average of 3 days

While newborns received phototherapy treatment, cotton wool moistened with breast milk in a container was placed near the newborn's nose.

To evaluate the bilirubin level of breast milk odor during phototherapy treatment

时间窗: Upon completion of the study, an average of 3 days

While newborns received phototherapy treatment, cotton wool moistened with breast milk in a container was placed near the newborn's nose.

次要结局

未报告次要终点

研究者

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

Elif Nilay Kizilay

nurse

Eskisehir Osmangazi University

研究点 (2)

Loading locations...

相似试验