CTRI/2017/11/010642已完成3 期
Randomized controlled trial comparing new generation incubator versus radiant warmer for care of extremely low birth weight infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time taken to regain birth weight
研究概览
简要总结
The aim of this RCT is to compare the effect of closed vs open care system of thermoregulating devices on various neonatal outcomes. The sample size is calculated using formula for the hypothesis of 2 parallel sample means. Average time taken to regain birth weight in less than 1000gms in radiant warmer in our NICU is 18 days. We hypothesize with use of incubator birth weight will be reached by 15 days. For a difference of 3 days with an error of 0.05 and beta error of 0.1 (power 90%) the estimated sample size is 22 in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates admitted on Day0 of life with birth weight <1000 grams.
排除标准
- •Congenital anomalies incompatible with life Neonates less than 24 weeks of gestation.
结局指标
主要结局
Time taken to regain birth weight
时间窗: From birth to 1 month of postnatal age
次要结局
- Total fluid intake in first 3 days of life(Birth to 3 days of postnatal age)
- Total fluid intake in first 7 days of life(From birth to 7 days of postnatal age)
- Highest serum sodium level in first 3 days of life(From birth to 3 days of postnatal age)
- Incidence of hypernatremia(From birth to 3 days of postnatal age)
- Incidence of hemodynamically significant PDA(From birth to 7 days of postnatal age)
- Incidence of definite necrotising enterocolitis(From birth till discharge)
- Incidence of culture positive sepsis(From birth till discharge)
- Incidence of ROP requiring treatment(From birth till discahrge)
- Incidence of Periventricular leucomalacia(From birth till discharge)
- Incidence of chronic lung disease(From birth till discharge)
- Duration of respiratory support(From birth till discharge)
- Incidence of IVH grade 3 or 4(From birth till discharge)
- Duration of hospital stay(From birth till discharge)
- weight at discharge(From birth till discharge)
- Length at discharge(From birth till discharge)
- Head circumference at discharge(From birth till discharge)
- All cause mortality(From birth)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨Cutaneous LeishmaniasisNCT02687971Drugs for Neglected Diseases130
已完成
1 期
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's NeuromaIntermetatarsal NeuromaNCT02838758Icahn School of Medicine at Mount Sinai10
尚未招募
不适用
A clinical trial to study temperature rise and antibacterial activity of diode laser for cavity disinfection at two different power settingsCTRI/2019/10/021756DR SAKSHI JAIN10
已完成
不适用
Cryopneumatic Device After Shoulder SurgeriesShoulder InjuriesShoulder DiseaseNCT04185064Encore Research Inc.200
已完成
不适用
Tarp Assisted Cooling of Hyperthermic IndividualsHealthyNCT04095403State University of New York at Buffalo15