Scale Development ,Content Validation and Reliability Testing of Neonatal Cardio-pulmonary Outcome Measure (N-COM) in Neonates Admitted in Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Neonatal Cardio-pulmonary outcome measure (N-COM)
研究概览
简要总结
Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU). There are many scales available which are helpful for assessing behavior, pain, and neurological status of neonates but there is no scale available till now which can help to assess cardio-pulmonary status of neonates.
详细描述
Background:
Neonatal Intensive care unit (NICU) is exclusively created to treat premature and fragile neonates. The neonates with intrauterine growth limitations with congenital heart defects and respiratory diseases are at increased risk of mortality. There are several scales to assess pain, behaviour, motor changes, growth and other components of neonates. In the past, no scale is available to evaluate the cardio-pulmonary status of the neonates in NICU.
Objectives:
The objective of the study is to develop an outcome measure for checking the cardio-pulmonary status of the neonate in the Neonatal Intensive care units (NICU), as Neonatal cardio-pulmonary outcome measure (N-COM) and to validate the domains of the scale, to check the reliability and minimum desirable change (MCID).
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 28 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm and full term neonates with cardio-pulmonary conditions Stable Neonates
排除标准
- •Neonates with severe disability Parents who are not wiling to participate their newborn in study
结局指标
主要结局
Change in Neonatal Cardio-pulmonary outcome measure (N-COM)
时间窗: Baseline, PRE INTERVENTION, 1 year POST INTERVENTION
Changes in pre and post Neonatal-cardio-pulmonary outcome measure (N-COM) will be noted. In pulmonary system, cyanosis (peripheral and central cyanosis), nasal grunting, chest retractions, respiratory rate, SPO2, nasal flaring, chest symmetry etc will be checked. In the cardiovascular system, heart rate, pulse rate, congenital heart defects, chest symmetry, heart sounds etc will be checked.
次要结局
未报告次要终点
研究者
Asir John Samuel
Associate Professor
Maharishi Markendeswar University (Deemed to be University)