Early Kangaroo Mother Care Versus Standard Neonatal Nursing Practices: A Randomized Controlled Trial on Survival and Nursing Outcomes in Preterm Infants (<2000 g) With Mild to Moderate Respiratory Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Survival Rates
研究概览
简要总结
This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams with mild to moderate respiratory distress. Utilizing a randomized controlled trial design, the research will be conducted in neonatal intensive care units (NICUs) across selected hospitals. Primary outcomes include infant survival rates, incidence of complications, and measures of maternal-infant bonding. Secondary outcomes involve nursing practices, caregiver satisfaction, and long-term developmental milestones. The use of validated, free assessment tools will ensure reliability and accessibility. Findings from this study are expected to inform best practices in neonatal care, potentially leading to improved health outcomes for preterm infants.
详细描述
Preterm birth, defined as delivery before 37 weeks of gestation, is a leading cause of neonatal morbidity and mortality worldwide. Infants weighing less than 2000 grams are particularly vulnerable to complications, including respiratory distress syndrome (RDS), which can significantly impact survival rates and long-term development. Traditional neonatal nursing practices focus on providing respiratory support, maintaining body temperature, and ensuring adequate nutrition. However, emerging evidence suggests that Kangaroo Mother Care (KMC), which emphasizes skin-to-skin contact and exclusive breastfeeding, may offer superior outcomes for preterm infants.
Kangaroo Mother Care (KMC) KMC involves continuous skin-to-skin contact between the mother and infant, promoting thermal regulation, enhancing breastfeeding, and fostering maternal-infant bonding. Studies have indicated that KMC can reduce mortality rates, lower the incidence of infections, and improve neurodevelopmental outcomes. Despite its benefits, the implementation of KMC varies across healthcare settings, and its comparative effectiveness against standard neonatal care practices warrants further investigation.
Objectives
- To compare the survival rates of preterm infants (<2000 g) with mild to moderate respiratory distress receiving early KMC versus standard neonatal nursing practices.
- To evaluate the impact of early KMC on nursing outcomes, including maternal-infant bonding and breastfeeding rates.
- To assess the feasibility and acceptability of implementing early KMC in NICUs.
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 (Participant, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to either the Early Kangaroo Mother Care group or control group using a computer-generated randomization sequence with block sizes of varying lengths to ensure allocation concealment and they are unaware of which group they have been assigned to as well as the outcome assessor is unaware
入排标准
- 年龄范围
- 28 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at <37 weeks of gestation.
- •Birth weight <2000 grams.
- •Diagnosed with mild to moderate respiratory distress (based on clinical criteria such as respiratory rate, oxygen saturation levels, and need for respiratory support).
排除标准
- •Infants with severe respiratory distress requiring mechanical ventilation.
- •Infants with congenital anomalies or other significant health issues.
- •Mothers unable or unwilling to provide KMC (e.g., due to medical conditions, lack of willingness).
研究组 & 干预措施
Early Kangaroo Mother Care Group
Early Kangaroo Mother Care Group:
- Initiation of KMC within 24 hours of birth.
- Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance.
- Support for exclusive breastfeeding or expressed breast milk feeding.
- Ongoing assessment and support from trained neonatal nurses and lactation consultants.
干预措施: Early Kangaroo Mother Care (Other)
Control Group
Control Group:
- Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines.
- Respiratory support as needed based on the severity of respiratory distress.
结局指标
主要结局
Survival Rates
时间窗: Up to 24 weeks
Survival Rates will be the proportion of preterm infants who survive following the implementation of KMC, a practice emphasizing continuous skin-to-skin contact and exclusive breastfeeding. For infants weighing less than 2000 grams, KMC has been associated with reduced mortality, particularly in low-resource settings where conventional neonatal care may be limited. By promoting physiological stability, enhancing maternal bonding, and reducing the risk of severe complications like infections and hypothermia, KMC offers a cost-effective and impactful approach to improving survival outcomes in this vulnerable population.
Incidence of Complications
时间窗: Up to 24 weeks
Incidence of Complications Including infections, intraventricular hemorrhage, and necrotizing enterocolitis.
次要结局
未报告次要终点
研究者
Nadia Elsharkawy
Associtae Professor
Jouf University