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临床试验/NCT05425394
NCT05425394已完成不适用

A Study of Effects of Delay in the First Bathing Time of Newborns on the Rate of Body Temperature and the Rate of Exclusive Breastfeeding: A Randomized Controlled Trial

Cardinal Tien Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年9月2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
90
试验地点
1
主要终点
body temperature after bath

研究概览

简要总结

Using delaying the first bathing by 8 hours as an interventional measure, considering the consistent effect of physiological maturity, newborns with a gestational age of ≥37 weeks were selected as the subjects in the nursery cases, and randomly assigned to the delayed bathing group and the routine bathing group , 10 minutes before bathing, immediately after bathing, 10 minutes, 30 minutes, and 60 minutes to analyze the differences in body temperature of the cases, and the differences in the rate of exclusive breastfeeding at discharge.

详细描述

The subjects of this study came from newborn babies in the nursery of a teaching hospital in the northern region. The research design was reviewed and approved by the Human Trials Committee. Can freely choose whether to participate in the research project or withdraw, willing participants to inform the research project and fill in the consent form and basic information form, inform that they can withdraw at any time during the research period, and divide the participating infants into the experimental group and the control group through a random allocation form , after the newborn arrives in the baby room, the nursing staff will evaluate the newborn, and then perform an oil bath with baby oil to remove the fetal fat on the body, and then follow the newborn bathing procedure of our hospital. Wash the whole body with water, about 1-2 hours after birth; the control group took the first bath as usual; the experimental group postponed the last step of washing the whole body after washing the face and head to 8 hours after birth , personnel must wear gloves to take care of newborns before bathing. The bathing process was performed by nurses in the baby room. Body temperature was measured 10 minutes before, immediately after, 10 minutes, 30 minutes, and 60 minutes after bathing, and the exclusive breastfeeding situation at the time of discharge was counted. After all measurements are completed, a 100 yuan supermarket coupon will be given.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Apparently normal newborn with status ranging from normal to good
  • •mean gestational age ≥37 weeks
  • •birth weight ≥2500 g
  • •Apgar score of at least 7 within 1-5 minutes
  • •birth rectal temperature ≥36.5°C
  • •without any major change or signs or symptoms of sepsis.

排除标准

  • •The mother is younger than 20 years old
  • •has recently had symptoms of fever, leukocytosis, respiratory tract infection or urinary tract infection
  • •the mother has diseases such as diabetes, hyperthyroidism, and a positive history of type B streptococcus or other blood and body fluid infectious diseases.

研究组 & 干预措施

delayed first bath time

Experimental

Delay first bath to 8 hours after birth

干预措施: Delay first bath (Behavioral)

regular bath

No Intervention

Birth temperature 36.5°C, regular bath

结局指标

主要结局

body temperature after bath

时间窗: temperature measurement : 10 minutes after bathing

The degree of decrease in body temperature after bathing compared to before bathing

次要结局

  • Exclusive breastfeeding rate(3 to 5 days)

研究者

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

Di-Ling Huang

Head nursing

Cardinal Tien Hospital

研究点 (1)

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