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临床试验/NCT05491265
NCT05491265Unknown不适用

Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Signs and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit : A Randomized Controlled Trail

Shaheed Zulfiqar Ali Bhutto Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Heart rate

研究概览

简要总结

- To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge

详细描述

The mother and baby will be supported by a nurse and researcher. Hence, the study group mothers will be trained properly, and the required information and explanations along with displaying the video description about the KMC method will be provided for them, and the KMC will apply to their newborns.

Thus, the naked newborn, only wearing diaper and cap, was placed in a straight state between the mother's breasts and supported by a cloth bag. The caring is performed for 3 consecutive days, three times a day and each time for 2-h.

The procedure will be conducted for all samples by the head nurse and with the researcher's presence and monitoring in the morning shift, and the mothers should be supported and encouraged during the caring process. The changes in pulse ,respiration, temperature, and arterial oxygen saturation rate of the study group is controlled and recorded during the care process, at 60 min after starting the procedure and at the end of caring process before returning the newborn to the incubator. The mentioned items in the control group (conventional incubator care) should also measure and recorded simultaneously with the study group. The pulse oximetry in NICU used to measure the arterial oxygen saturation rate, and a mercury thermometer was used to measure the temperature with an auxiliary approach for 3 min. To maintain the reliability of the instrument during the research, the same pulse oximetry device and monitoring system will be applied to newborns in the same situation. The pulse oximetry probe will be taped to the toe of the left foot of all newborns

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
None

入排标准

年龄范围
28 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Birth weight between 1200 to 1800 gram Gestational age 28 weeks to 36+6 weeks Clinically stable Off oxygen support Hemodynamically stable baby No surgery performed on baby No cardiac ,nervous system problems

排除标准

  • •Extreme preterm<28 weeks Hemodynamically unstable Underlying cardiac problems Surgical problems Those who do not give consent Unwell or hospitalized mother who is bed bound problems Gestational age 37 weeks or >37 weeks

研究组 & 干预措施

Kangaroo mother care

Experimental

To see the impact of intermittent kangaroo mother care on temperature ,oxygen saturation and heart rate.

干预措施: Intermittent Kangaroo mother care (Behavioral)

standard of care

No Intervention

To observe temperature ,oxygen saturation and heart rate in preterm neonates not given kangaroo care

结局指标

主要结局

Heart rate

时间窗: 2 hours

To measure heart rate variations in babies provided with kangaroo mother care vs incubator care

Temperature

时间窗: 2 hours

To measure temperature difference in babies provided with kangaroo mother care vs incubator care

Oxygen Saturation

时间窗: 2 hours

To measure oxygen saturation in babies provided with kangaroo mother care vs

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maimoona Saeed

MD Resident

Shaheed Zulfiqar Ali Bhutto Medical University

研究点 (1)

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