Emollient Therapy for Improved Survival and Growth of Very Low Birth Weight Infants in Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Compare mortality rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days
研究概览
简要总结
The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates.
详细描述
For infants whose parent/caretaker provides written informed consent, the study nurse coordinator on-site will allocate infants to one of two strata (700- <1000 g or 1000-1500 g). Participants within each stratum will be randomly assigned in a 1:1 ratio to one of two treatment groups: 1) high-linoleate SSO, or 2) standard-of-care treatment without use of topical emollients or massage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the visible nature of the intervention, it is not possible to completely mask allocation; thus, the trial will be open-label. However, study physicians will not have access to patient randomization lists.
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants <72 hours of age
- •weigh 700-1500 at birth
- •hospitalized at SMCH
排除标准
- •infants who are moribund and highly likely not to survive despite any intervention
- •significant breaches in their skin barrier
- •conditions indicating failure to gain weight
- •critically ill (definition below):
- •Oxygen saturation <88% on oxygen therapy AND ≥2 of the following conditions:
- •respiratory rate <20 or >100 breaths per minute
- •apnea requiring bag-mask ventilation
- •heart rate <100 or >200 beats per minute
- •congenital syphilis
- •hydrops fetalis
- •a life-threatening congenital anomaly or major surgical condition requiring intervention
- •generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function
研究组 & 干预措施
Emollient arm
Infants will receive gentle, hygienic whole-body massage by trained nurses (not parents or other family members) with 3g of SSO per kg of body weight - a dose sufficient to saturate the skin - three times daily for the first 14 days and twice daily thereafter during the duration of their stay in the hospital until death, discharge or through day 28 after birth.
干预措施: Topical Emollient Therapy (Other)
Control arm
Infants in the control group will receive the standard of care for infants in the neonatal care unit, which does not include use of topical emollients or massage (i.e., family members will not be allowed to apply skin care products to their infants), or other particular measures to prevent skin breakdown or to modulate skin barrier function.
结局指标
主要结局
Compare mortality rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days
时间窗: Baseline and 28 days
This will be an intent-to-treat analysis, using the randomization level rather than the received level of intervention. To estimate the change in mortality rate, we will use a maximum likelihood approach, operationalized as a logistic model with fixed effects for study arm and strata random effects.
次要结局
- Compare growth rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days.(Baseline and 28 days)
研究者
Gary Darmstadt
Professor of Pediatrics
Stanford University