Topical Coconut Oil Application and Incidence of Sepsis in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Late-onset sepsis rate for intervention versus control
研究概览
简要总结
The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.
详细描述
Purpose and Specific Aims
The purpose is to determine the effect of twice daily topical coconut oil application on late onset sepsis in neonates admitted to the Neonatal Intensive Care Units of Indira Gandhi Institute of Child Health, Cloudnine Hospital at Old Airport Road, and Cloudnine Hospital at Jayanagar in Bangalore, India. The aim is to determine the effect of topical coconut oil application on:
- The incidence of neonatal late onset culture positive sepsis
- Neonatal skin integrity versus a no treatment control using standard skin evaluation methods
- Biomarkers of neonatal innate immune function
- Temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality.
The investigators hypothesize that twice daily topical coconut oil application will reduce the incidence of late onset sepsis (LOS) in premature and full-term infants versus the current standard of care, i.e., no treatment. The oil treatment will increase the neonatal skin barrier integrity measured by validated clinical and instrumental methods. Skin surface biomarkers of innate immune function collected from coconut oil treated skin will indicate less inflammation (lower proinflammatory cytokine levels) than in untreated control skin.
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)
盲法说明
Subjects will be randomly assigned to receive coconut oil or no treatment using a random number scheme after stratification for gestational age group
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants 24-36 weeks gestational age
- •Full-term infants 37-42 weeks gestational age
- •Less than 48 hours of age at enrollment
- •Admitted to the neonatal intensive care unit of Indira Gandhi Institute for Child Health, Cloudnine Hospital at Old Airport Road and Cloudnine Hospital at Jayangar, Bangalore
- •Expected to be in the neonatal intensive care unit for at least 4 days after enrollment
- •Able to tolerate study procedures as described
- •Parent/guardian willing to provide written informed consent
排除标准
- •Medically unstable
- •Parent/guardian unable to provide written informed consent
- •Presence of inherited cutaneous condition e.g., scalded skin syndrome, epidermolysis bullosa
- •Presence of major congenital anomalies
- •Infants undergoing surgery
结局指标
主要结局
Late-onset sepsis rate for intervention versus control
时间窗: Day 3 of life until discharge or day of life 28, whichever occurs first
Incidence of late-onset sepsis is defined as an infection that occurs on or after day 3 of life
次要结局
- Skin rash(Day 3 of life until discharge or day of life 28, whichever comes first)
- Skin dryness(Day 3 of life until discharge or day of life 28, whichever comes first)
- Skin erythema(Day 3 of life until discharge or day of life 28, whichever comes first)
- Skin transepidermal water loss(Day 3 of life until discharge or day of life 28, whichever comes first)
- Skin surface acidity (pH)(Day 3 of life until discharge or day of life 28, whichever comes first)
- Set of skin surface proteins of known innate immune function(Day 3 of life until discharge or day of life 28, whichever comes first)
- Skin Microbiome(Day 3 of life until discharge or day of life 28, whichever comes first)
- Chronic lung disease(Day 3 of life until discharge or day of life 28, whichever comes first)
- Causative Organisms of Sepsis(Day 3 of life until discharge or day of life 28, whichever comes first)
- Necrotizing enterocolitis(Day 3 of life until discharge or day of life 28, whichever comes first.)
研究者
Vivek Narendran, MD
Professor of Pediatrics
Children's Hospital Medical Center, Cincinnati