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临床试验/NCT02760966
NCT02760966Unknown不适用

Effectiveness of Alcohol 70º Compared With Soap on Cord Separation Time and the Complication Rate in the Newborn

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
34
试验地点
1
主要终点
Time of cord separation

研究概览

简要总结

Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the complication rate in the newborn.

详细描述

Randomized clinical trial, which objective is to assess the effectiveness of 70º alcohol compared with neutral soap on the cord separation time of a selection of newborns. 34 newborns admitted to the maternity ward of the hospital have participated. The study is divided into two phases, hospital and home. The first stage is located in the hospital, where the patients who will become part of the study are chosen. After receiving the informed letting of the legal guardian the second part of this phase is started; which aim is to explain the steps to be followed to make a correct cleaning cord technique. The home phase consists of being in contact with the family through Whatsapp on the 5th day from birth, the day of the cord fall and 5 days after this fall. Making some simple questions with simple answers such as yes or no and with the possibility, or not, of sending a picture of the cord state in each follow-up visit.

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
None

入排标准

年龄范围
6 Hours 至 20 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Availability of legal guardians with knowledge and access to Whatsapp.

排除标准

  • •Admission in the newborn's room.
  • •Patients with strong concomitant illness, that limits the planned activities or whose current state contraindicates the incorporation of the program.
  • •Mother's age < 18 years old.
  • •Bad controlled mother's diabetes (at least two digits of blood glucose <180 mg/dl per day), bad alimentation control and/or non-adherence.

研究组 & 干预措施

Alcohol 70º

Experimental

Umbilical cord care will be carried out using alcohol 70º at least 3 times a day. Firstly, there must be a proper hand hygiene. Then, with sterile gauzes alcohol will be applied from the abdominal part to the end of the stump.

干预措施: Alcohol 70º (Other)

Soap

Active Comparator

Umbilical cord care will be carried out using soap at least 3 times a day. Firstly, there must be a proper hand hygiene. Then, with sterile gauzes alcohol will be applied from the abdominal part to the end of the stump.

干预措施: Soap (Other)

结局指标

主要结局

Time of cord separation

时间窗: 15 days

Examine the differences in the cord separation time between alcohol 70º and soap.

次要结局

  • Omphalitis(28 days)
  • Unscheduled consultations(60 days)
  • Umbilical cord infection(28 days)
  • Pneumonia(28 days)
  • Diarrhea(28 days)
  • Tetanus(28 days)
  • Emergency department admissions(60 days)
  • Neonatal mortality(60 days)
  • Hospital admissions(60 days)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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