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临床试验/NCT02052284
NCT02052284已完成不适用

The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants

George Washington University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月最近更新:
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
30
试验地点
2
主要终点
Daily fluid intake (ml/kg/day)

研究概览

简要总结

Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area. Loss of fluids is associated with many complications. The investigators hypothesize that application of sterile water to the skin of these infants is associated with decreased fluid requirements in the first week of life , improve skin integrity and decrease some complications of prematurity.

详细描述

Extremely low birth weight (ELBW) infants have significant transepidermal water loss immediately after birth. This significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. Water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. In order to compensate for these losses, clinicians have to progressively increase fluid intake. Excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (PDA), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and mortality. Also skin integrity is important to protect against skin infection and secondary sepsis. Based on recent studies and relevant data, the risk of sepsis in ELBW is up to 40% nationwide, but only about 25% at GWUH Water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. The current practice at GWUH is to clean the bodies of premature infants using a piece of damp cloth with warm water. This is performed at birth and consequently every other days. The study group will receive more frequent and standardized applications. The investigators hypothesize that application of sterile water in ELBW infants is associated with decreased fluid requirements in the first week of life. As a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of BPD with no increased incidence of skin or systemic infections.

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
Double (Participant, Care Provider)

入排标准

年龄范围
— 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Extremely Low Birth Weight (less than 1000 grams at birth), and
  • Less than 24 hours of life

排除标准

  • Major congenital anomalies
  • Malformations or other surgical emergencies requiring immediate transfer.
  • Major skin abnormalities

研究组 & 干预措施

Control

No Intervention

The control group will receive standard skin care of the NICU, which does not include specific measures to modulate skin-barrier function.The current practice at GWUH NICU is that nurses clean the bodies of newborns less than 1000 grams using a piece of damp cloth with warm water. This is performed at birth and consequently every other days.

Water wash

Experimental

The study group will undergo a protocol of sterile water application in addition to routine skin care of the NICU. The study group will receive more frequent and standardized applications. A commercially sterile water bottle (Enfamil® Water) will be kept inside the isolette, to be maintained at isolette temperature, and will be changed on a daily basis. Nurses use sterile gloves as a routine for care of ELBW infants. A 2 inches x 2 inches sterile gauze will be soaked in sterile water and gently applied to all skin of the baby excluding umbilical cord and IV lines sites. This procedure will be repeated every 4 hours with routine patient care for the first 1 week of life.

干预措施: Sterile water application (Other)

结局指标

主要结局

Daily fluid intake (ml/kg/day)

时间窗: First 7 days of life

The primary outcome is daily fluid requirements in the first week of life. Daily fluid requirements from Day1 to Day7 will be compared between intervention and control groups.

次要结局

  • Peak total bilirubin (mg/dl)(Participants will be followed for the duration of hospital stay, an expected average of 16 weeks)
  • Incidence of significant PDA(Participants will be followed for the duration of hospital stay, an expected average of 16 weeks)
  • Incidence of NEC(Participants will be followed for the duration of hospital stay, an expected average of 16 weeks)
  • Incidence of BPD(Participants will be followed for the duration of hospital stay, an expected average of 16 weeks)
  • Length of stay (days)(Participants will be followed for the duration of hospital stay, an expected average of 16 weeks)
  • Incidence of change in microbiological skin colonization(First week of life)
  • Skin Score(First 7 days of life)
  • Incidence of culture proved sepsis(Participants will be followed for the duration of hospital stay, an expected average of 16 weeks)

研究者

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

Mohamed ElDib

Assistant Professor of Pediatrics and of Neurology

George Washington University

研究点 (2)

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