Skin Integrity After Newborns' First Bath And Development of Eczema and Allergy at 2 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in skin transepidermal water loss (TEWL)
研究概览
简要总结
Atopic dermatitis (AD) is a chronic allergic skin disease with onset in early childhood and increasing prevalence in Westernized countries. Current well newborn guidelines for washing babies with soap were adopted by U.S. hospitals in the 1970s, before the rise in prevalence of allergic disease and AD (also called eczema). Increased transepidermal water-loss (TEWL) in newborn skin at 2 days of life was recently identified as a predictor of AD and allergy development by age 2 years. Risk for AD in babies was also linked to decreased skin colonization with certain skin microflora, such as staphylococcal organisms. Together, these data raise the question of whether newborn skincare guidelines have the potential to modify a baby's risk for allergy development. Our current practice of washing babies with soap may alter TEWL or other natural factors in skin that protect babies from development of AD and allergy. More knowledge is needed about the impact of infant skincare practices on allergy development.
The objective of this pilot study is to determine the impact of a baby's first bath on his/her transepidermal water loss (TEWL) and skin microflora. Study procedures will include collection of TEWL measurements and skin swabs for skin microflora analysis pre/post first bath in healthy term newborns at UVA. This data will serve as preliminary data for future studies.
详细描述
The UVA study team will perform all study-related procedures and will collect all data. Contact information and permission for the study team to contact the subject's family will be obtained at enrollment.
Pre-bath Procedures: Prior to the first bath, a study team member will:
- Record health information about the subject.
- Record the amount of vernix covering the subject's skin.
- Measure skin TEWL (see TEWL below).
- Procure skin swabs for microflora analysis (see Skin swabs below)
Post-bath Procedures: Following the subject's first bath, a study team member will repeat pre-bath procedures.
TEWL Procedure TEWL measurement will be performed using the Tewameter - a non-invasive, wand-like instrument that sits atop skin like a stethoscope and measures the water evaporating from the skin. TEWL is a validated non-invasive procedure for assessment of newborn skin integrity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term (>36 weeks GA) baby
- •Born at UVA
- •Admitted to the well newborn nursery
- •Baby's mother is at least 18 years old and capable of providing informed consent
排除标准
- •Babies born to cognitively-impaired mothers (unable to provide consent).
- •Babies of prisoners.
- •Babies of non-English speaking mothers (due to limited resources available for study conduct).
- •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant or would render the participants unable to comply with the protocol.
结局指标
主要结局
Change in skin transepidermal water loss (TEWL)
时间窗: Within baby's first 72 hr of life, TEWL will be measured at baseline and then at 18 to 36 hours after their first bath in the hospital
Change in TEWL, before (baseline) versus after baby's first bath, will be measured.
次要结局
- Skin microorganisms(Within baby's first 72 hr of life, skin will be swabbed for microflora at baseline and then at 18 to 36 hours after their first bath in the hospital)
- Number of participants with physician-diagnosis of atopic dermatitis and allergy(At 2 years of life, subjects will be assessed for any physician-diagnosis of atopic dermatitis (AD) or allergy during their first 24 months of life)
研究者
Ann Kellams, MD
Associate Professor
University of Virginia