To Study the Effect of Kangaroo Mother Care on Duration of Phototherapy in Neonatal Jaundice; A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- duration of phototherapy required
研究概览
简要总结
Kangaroo Mother Care [KMC] consists of skin to skin contact between mother and infant in a vertical position (kangaroo position). It helps in preventing hypothermia, stabilizes physiological parameters, significantly increases breast milk production, improves weight gain and helps in early discharge. Phototherapy is the mainstay of treating hyperbilirubinemia in neonates. During phototherapy the neonate is kept naked under the light in a cot and is taken out only for breastfeeding. Hence during phototherapy there is lack of contact between mother and baby which deprives the baby from the benefits of KMC. This study proposes to analyze the effect of intermittent KMC in neonatal jaundice. By giving phototherapy along with KMC in one group and only photoherapy in another, this study will show if KMC is effective in reducing the duration of phototherapy required in neonatal jaundice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •1.hemodynamically stable neonates admitted in NICU 2.gestational age 30 to 40 weeks 3.weighing more than 1000 but less than 2000 gram 4.requiring phototherapy as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age.
排除标准
- •1.Patient with major congenital malformations 2.Unstable patients on CPAP (Continuous Positive Airway Pressure) or on ventilator or requiring ionotropes.
- •3.Patient requiring exchange transfusion as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age .
- •4.Patient presenting with jaundice in first 24 hours of life with rate of rise of bilirubin > 5 mg/ dl/day.
结局指标
主要结局
duration of phototherapy required
时间窗: duration of phototherapy required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age
次要结局
- rate of fall in serum bilirubin(rate of fall in serum bilirubin during phototherapy required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age)
- weight gain per day(weight gain per day during phototherapy required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age)
- temperature maintenance(temperature is measured eight hourly or before , duringand after KMC till phototherapy is required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age)
- hospital stay(discharge of patient from NICU)