A randomized, controlled trial to study the efficacy of Embrace Infant Warmers in maintaining thermostability of low birth weight neonates against conventional care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ability of the Embrace Infant Warmer to support neonatal thermostability within the range of 36.5oC to 37.5oC.
研究概览
简要总结
This pilot clinical study is a 1:1 randomized, open-label, active controlled trial to study the efficacy of Embrace Infant Warmers in maintaining thermostability of low -birth-weight neonates against conventional care for 4 months in 20 patients at a single center in India.
The primary outcome is to determine the ability of the Embrace Infant Warmer to support neonatal thermostability within the range of 36.5oC to 37.5oC, during the study treatment phase, lasting for 4 hours, as determined by axillary or skin probe temperature reading.
Neither the concerned medical device nor its comparator are listed under notified medical devices, by the Ministry of Health and Family Welfare, Government of India (20/April/2010). Hence the DCGI approval to conduct pilot clinical study for this device is not needed. However the DCGI has been notified on 02/July/2010 and acknowledgment for the same has been received on 13/July/2010.
The study is intended to be conducted broadly on clinically stable low-birth-weight neonates who need external thermal support to maintain normothermia.
Data analysed from the study thus conducted was submitted and accepted for presentation at the Pediatric Acedemic Societies (PAD), Denever in 2011-"Pilot Randomized Clinical Trial of a Portable Infant Warmer Not Dependent on a Continuous Energy Supply; Rahul A Panicker, PhD1, Kishore Kumar, MD2,3,4, Naveen Bekappa, MD4, Swarna R Bhat, MD4, Karthik N Nagesh, MD4 and Kiran Tauro, MD3. 1Embrace, San Francisco, California, United States; 2Department of Pediatrics and Neonatology, Notre Dame University, Perth, Western Australia, Australia; 3The Cradle, Bangalore, Karnataka, India and 4 Bangalore Neonatal Network at Division of Neonatology, Stanford,Stanford Univeristy, Stanford, California, United States"
Conduct of the study confirms the cinical feasibility of the Embrace Infant Warmer to provide thermoregulatory support for newly born low-birth-weight infants. A multicenter study powered to upscale its application and assess for a potential adverse events is advised.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Clinically stable neonates (not on external oxygen supply, not on IV fluids, and vital signs within the normal limit.
- •Vital signs involve the measurement of the respiratory rate, heart rate and CRT)
- •1500 grams to 2500 grams at time of screening 3.Gestation period greater than 32 weeks.
- •4.Signed and dated Informed Consent Document.
排除标准
- •1.External supply of oxygen or intravenous fluids2.Malformation that adversely affects the temperature of the neonate3.Parental refusal to participate.
结局指标
主要结局
Ability of the Embrace Infant Warmer to support neonatal thermostability within the range of 36.5oC to 37.5oC.
时间窗: During the study ?treatment phase?, lasting for 4 hours, as determined by axillary or skin probe temperature reading.
次要结局
- Maintain the temperature of the micro-environment in the Embrace Infant Warmer.(During the "study treatment phase" that lasts for 4 hours.)
- Compare the mean temperature of neonates in the study group and control group (receiving standard care)(During the "study treatment phase", that lasts for 4 hours, and determined by axillary or skin probe temperature reading.)
- Verify the sterility of the Embrace Infant Warmer when being used for multiple neonates(Compared to the device used in the standard of care arm before use in a neonate and immediately post removal of the neonate form the device)
- Efficacy of the Embrace infant warmer in maintaining temperature of the neonate within the range of 36.5oC to 37.5oC(During the "study treatment phase", that lasts for 4 hours, and determined by axillary or skin probe temperature reading.)