Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urinary biomarkers of energy utilization
研究概览
简要总结
This study aims to assess the impact of kangaroo mother care on energy utilization in preterm neonates by measuring urinary levels of xanthine, uric acid, and malondialdehyde.
It also aims to evaluate the effect of kangaroo mother care on physiological stress parameters in preterm neonates, as well as maternal emotional status
详细描述
This randomized controlled clinical trial aims to evaluate the effect of kangaroo mother care on energy utilization and oxidative stress in preterm neonates admitted to the neonatal intensive care unit (NICU) at Ain Shams University Children's Hospital, Cairo, Egypt.
Preterm neonates with gestational age between 32 and 36 weeks who meet the eligibility criteria will be enrolled and randomly assigned into two groups: an intervention group receiving kangaroo mother care and a control group receiving routine incubator care.
All enrolled neonates will receive routine incubator care until day 3 of life. On day 3, the intervention group will receive one hour of kangaroo mother care provided by the mother after feeding, while the control group will receive one hour of standard nursing care without kangaroo mother care.
Physiological parameters, including heart rate, respiratory rate, oxygen saturation, and temperature, will be monitored at baseline and every 15 minutes during the intervention period.
Urine samples will be collected from neonates 3 hours before and 3 hours after the intervention to measure biomarkers of energy utilization (xanthine and uric acid) and oxidative stress (malondialdehyde) using ELISA kits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm neonates (32-36 weeks)
- •Vitally stable
- •On room air or low ventilatory support
排除标准
- •Neonates requiring surgery
- •Intraventricular hemorrhage
- •Receiving sedatives (morphine, fentanyl, midazolam)
- •Renal impairment
- •Congenital anomalies
- •Cyanotic heart disease
- •Severe respiratory distress
- •Hemodynamic instability
- •Hypothermia
- •Parental refusal
研究组 & 干预措施
study group
babies at day 3 will have kangro mother care
干预措施: kangroo mother care (Behavioral)
control group
will have routine incubator care
干预措施: routine incubation care (Behavioral)
结局指标
主要结局
Urinary biomarkers of energy utilization
时间窗: 3 hours before and 3 hours after intervention on day 3 of life
Urinary xanthine and uric acid levels measured using ELISA kits.
Oxidative stress marker
时间窗: 3 hours before and 3 hours after intervention on day 3 of life
Urinary malondialdehyde level measured using ELISA kits.
heart rate
时间窗: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Heart rate measured using standard neonatal monitoring devices.
Respiratory rate
时间窗: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Respiratory rate measured using standard neonatal monitoring devices.
temperature
时间窗: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Body temperature measured using standard neonatal monitoring devices.
次要结局
- maternal emotional status(Time Frame: 3 hours before and 3 hours after intervention on day 3 of life)
- maternal emotional status(: 3 hours before and 3 hours after intervention on day 3 of life)
研究者
Salwa Amin Abd Elhamid
assisstant prfessor
Ain Shams University