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临床试验/NCT05692648
NCT05692648已完成不适用

Effect of Repositioning Frequency on Bilirubin Level and Infant Comfort in Neonates Receiving Phototherapy

Selcuk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2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
60
试验地点
1
主要终点
comfort level questionnaire

研究概览

简要总结

Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

Design and methods: This was a single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial conducted in a neonatal intensive care unit. Participants were randomly assigned to one of three groups: Supine position group (n = 20), hourly position change group (n = 20), and control group (n = 20). The bilirubin level and comfort levels of the neonates were evaluated.

详细描述

Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

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)

盲法说明

single (participant, outcomes assessor)

入排标准

年龄范围
35 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •gestational age between 35-42 weeks
  • •birth weight of 2000 g or more
  • •indication for phototherapy
  • •no previous phototherapy,
  • •no medical diagnosis other than prenatal hyperbilirubinemia
  • •stable health status
  • •no clinical signs of dehydration
  • •transition to oral feeding, no sucking problems
  • •being at least 2 days old on the day of phototherapy

排除标准

  • •a sudden change in stability during phototherapy and
  • •phototherapy duration of less than 24 hours

研究组 & 干预措施

Supine position group

Experimental

These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.

干预措施: Supine position group (Behavioral)

Hourly position change group:

Experimental

Infants in this group were repositioned "every hour" based on the time of phototherapy initiation. Neonates were initially placed in supine position and then changed to the prone position. Infants were alternated between supine and prone positions every hour for 24 hours.

干预措施: Hourly position change group (Behavioral)

Control Group (2-hour position change)

Other

Neonates in this group were repositioned every 2 hours as routine practice based on the time of phototherapy initiation.

干预措施: Control Group (2-hour position change) (Behavioral)

结局指标

主要结局

comfort level questionnaire

时间窗: up to 24 hours

comfort level change

Change in bilirubin level

时间窗: Baseline and 24 hours after phototherapy

bilirubin level change

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

Sevinc Akkoyun

lecturer (Phd)

Selcuk University

研究点 (1)

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