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临床试验/NCT04156529
NCT04156529已完成不适用

The Effect of Two Different Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants

Sibel Serap Ceylan2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2019年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Neonatal pain

研究概览

简要总结

Premature infants have a need for an orogastric or nasogastric feeding tube because of the immaturity of coordination between suck-swallow and breathing. Tube feeding could cause feeding intolerance and stress. One of the recommendations to prevent feeding intolerance is giving suitable position during tube feeding. Also, feeding intolerance is related to stress. The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF). This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF.

详细描述

Purpose: The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF).

Method: This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF. The sample size calculation was based on the crossover design. It assumed criteria that included the expectation of minimal differences in the average pain and stress score, 1.0; a difference of 2.0 in the standard deviation between ESU and ESRL positions; power, 0.80 and p < .05. The sample size was calculated to be 34 participants. The inclusion criteria for participants were 30-34 weeks gestational age, stable vital signs, no oral feeding skills, feeding by orogastric tube, and had parental consent. Exclusion criteria were respiratory distress, congenital anomalies, necrotizing enterocolitis history, neurological and cardiological problems, receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress. The position to be given to the participants during TF first was determined by randomization. The sequence of feeding position was randomized by computer. Sixteen of the infants started TF with ESU position, whereas the other 18 started with ESRL position.

The study data were collected with "Descriptive Properties Form of Premature Newborn", Premature Newborn Follow-up Form", "Newborn Stress Scale", "ALPS-Neo Newborn Pain and Stress Assessment Scale".

For each participant, two feeding positions were applied at consecutive feeding time. Feeding tolerance was assessed by abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF. Vital signs and oxygen saturation levels were measured before, during and after TF. The stress and pain levels of the participants were evaluated independently by the researchers before, during and after TF. Significance level p <0.05 was used for all statistical analyses. Ethics committee approval, written permission from institutions and families were obtained for conducting the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
30 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 30-34 weeks gestational age,
  • stable vital signs,
  • no oral feeding skills,
  • feeding by orogastric tube,
  • had parental consent

排除标准

  • respiratory distress,
  • congenital anomalies,
  • necrotizing enterocolitis history,
  • neurological and cardiological problems,
  • receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress

结局指标

主要结局

Neonatal pain

时间窗: Four month

ALPS-Neo Newborn Pain and Stress Assessment Scale was used. The ALPS-Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.

Neonatal stress

时间窗: Four month

Newborn Stress Scale was used. The scale includes eight items: face expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each item is scored on the scale 0-2. The minimum score is 0 and the maximum score is 16. As the score increases, the stress level of the infant increases.

Feeding intolerance

时间窗: Four month

Abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF.

次要结局

  • Respiratory Rate(Four month)
  • Heart Rate(Four month)
  • Oxygen Saturation(Four month)

研究者

发起方
Sibel Serap Ceylan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sibel Serap Ceylan

Principal Investigator

Pamukkale University

研究点 (2)

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