The effect of the ESL and the ESU position on physiological parameters, pain and stress and feeding tolerance of preterm neonates during Oro-gastric tube feeding in an NICU of tertiary care hospital - A randomized controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in pain and stress of preterm neonate during OG Tube feeding.
研究概览
简要总结
Prior permission obtained from the Principal, College of Nursing.
Permission will be taken from Head of the department of Neonataolgy
Ethical approval obtained from Institute Ethics Committee, AIIMS, Bhubaneswar.
Precautions for patient safety and the reduction of environmental stimuli will be taken before Tube Feeding. Measures will be taken to ensure patient safety include checking the enteral tube placement before Tube feeding. Feeding will be done slowly by gravity.
All preterm infants will be checked for the eligibility criteria and then data will be collected.
The form for infant descriptive characteristics will be filled for each infant before the feeding.
The pain and stress levels of the infants will be evaluated 2 mins before Tube feeding. Subsequently, the infants’ RR, HR, SpO2 levels, AC will be measured in the supine position and recorded.
The infant will then be randomised to AB OR BA Sequence. (A = semi-elevated right lateral position, B = semi-elevated supine position)
The infant will then be placed in the identified position and Tube Feeding commenced. The stress and pain levels of the infants will be assessed during Tube Feeding, and physiological changes will be measured during Tube Feeding. Infant feeding times will be measured and recorded.
After completion of feeding readings were taken in 1st, 5th, 15th,30th and 60th minutes.
In the next feeding the infant will be positioned in the alternate position and all the process will be repeated.
Positioning supports will be used for both positions. Also, in NICU, where the study is carried out, the feeding tubes remain indwelling in the baby.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 2.00 Month(s)(—)
- 性别
- All
入选标准
- •Preterm infants who were born at <34 gestational weeks, stable vital signs, orogastric tube feeding, and has parental consent.
排除标准
- •Preterm infants with necrotizing enterocolitis history, respiratory distress, congenital anomalies, neurological and cardiological problems and use of medication that may affect pain and stress levels such as analgesics, sedatives and muscle relaxants.
结局指标
主要结局
Reduction in pain and stress of preterm neonate during OG Tube feeding.
时间窗: Before, during and 1st,5th,15th,30th and 60th minute after feeding
次要结局
- Stabilisation of physiological parameters during tube feeding.(Before, during & 1st,5th,15th,30th & 60th minute after feeding)
研究者
Ayantika Chandra
AIIMS BHUBANESWAR
