跳至主要内容
临床试验/CTRI/2023/11/060366
CTRI/2023/11/060366尚未招募1/2 期

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

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2028年12月5日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ayantika Chandra

AIIMS BHUBANESWAR

研究点 (1)

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