跳至主要内容
临床试验/NCT03895242
NCT03895242已完成不适用

The Effect on Physiological Variables of Prone and Supine Positions Given to Preterm Infants Receiving Mechanical Ventilation

Akdeniz University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Oxygen Saturation

研究概览

简要总结

Positioning, which is one of the individualized developmental care methods, is known as the important care support process which is applied with the purpose of ensuring the least damage from the environmental. Positioning in preterm infants is the basis of neonatal nursing care. Positioning in preterm infants receiving mechanical ventilation support is important in terms of physiological and neurodevelopment. In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. In this respect, the aim of this study, designed as a randomized controlled trial, was to determine the effect of supine and prone positions on physiological variables (oxygen saturation and heart rate) of preterm infants receiving mechanical ventilation.

详细描述

In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. Therefore, the aim of this randomized controlled study, test the efficacy of two different positions (prone-supine) given to preterm newborns receiving mechanical ventilation.The study was conducted from February 2015 to June 2016.

Participants and setting:

We were interested in establishing the difference between the supine position and the prone position, with an error margin of 10%. According to the formula of the calculated sample size, for a crossover design with a = 0.05, the sample size required to achieve a 90% power is 36 infants. Thirty-eight infants who met the inclusion criteria of the study were selected and invited to participate. Of these, parents of 38 infants consented. A convenience sample of hospitalized preterm infants (less than 37 weeks gestational age) was selected from a tertiary neonatal intensive care unit of a teaching and research hospital in Turkey. Preterm infants were divided into two groups by randomization according to position priority (n = 38). First group was first supine position followed by prone position (n = 19), second group was first prone position, then supine position (n = 19). The priority of the positions to be given to preterm infants was randomly determined using the closed envelope method. The positions of infants were written in envelopes and closed. The clinical nurse, who was not in the research, pulled the envelope and identified position group of the infant . Thus, data were collected for both the prone and the supine position from a newborn.

Procedure and data collection:

The infants involved in the study were cared for in a incubator and wore diapers only. The temperature of the incubator was set to maintain a body temperature ranging from 36.5 to 37.2 °C. After necessary routine procedures such as diapering, body cleaning, weighing and suctioning were completed, each subject was randomly assigned to the supine-prone group or prone-supine group sequence. All of the positions of preterm infants were given carefully by the researcher.

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
None

入排标准

年龄范围
1 Day 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestation week from 25 to 36 weeks
  • Spontaneous breathing with mechanical ventilation (required ventilatory support and at least 12 hours in nasal continuous positive airway pressure therapy),
  • Postnatal age ≤ 7 days,

排除标准

  • Neuromuscular disease,
  • Pulmonary arterial hypertension,
  • Emphysema,
  • Active bleeding,
  • Respiratory problem due to heart disease,
  • Obstacle to give birth position congenital disorder,
  • Abdominal or thoracic surgery,
  • Hypothermia and hyperthermia,
  • Chest with tube,
  • Continuous sedative treatment,
  • Anticonvulsive therapy and cardiac drug therapy,
  • Mechanical ventilator settings vary frequently,
  • Preterm neonates with a frequency of more than three hours were not included in the study.

研究组 & 干预措施

Group 1:First supine position,then prone position

Experimental

First group was supine position then prone position.

干预措施: Group 1:Supine-Prone (Behavioral)

Group 2:First prone position, then supine position

Experimental

Second group was first prone position, then supine position.

干预措施: Group 2:Prone-Supine (Behavioral)

结局指标

主要结局

Oxygen Saturation

时间窗: An average of 2 year

Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.

Heart Rate

时间窗: An average of 2 year

The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.

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

Sultan Besiktas

Graduate Nurse

Akdeniz University

研究点 (1)

Loading locations...

相似试验