The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Gastric residual volume
研究概览
简要总结
This study is a PhD dissertation. In this study, the investigators aim to investigate the effects of three different positions after feeding on gastric residual volume, abdominal oxygenation using near infrared spectroscopy (NIRS), and fractional oxygen extraction values in preterm newborns.
详细描述
The Design of Research
This study was planned in a randomized crossover study design to evaluate the effects of three different positions on gastric residual volume, fractional oxygen extraction and abdominal oxygenation in clinically stable breastfed preterm newborns. The order of the 3 positions that will be given to the participants the research group will be determined by drawing lots and 3 intervention groups will be formed. The participants in each intervention group will be followed for two hours after feeding in all three positions: semi-elevated supine position, prone position, and right lateral position. Positions will be given to the participants, taking into account the order of positions in each group. All positions will be applied once to each participant. Groups and position rankings according to the result of the draw:
- st group: Prone, right lateral, and semi-elevated supine position;
- nd group: Semi-elevated supine, prone, and right lateral position;
- rd group: Right lateral, semi-elevated supine, and prone position;
48 participants in the study group will be randomly assigned to these 3 intervention groups. In order to determine which participant will be in which group, the numbers from 1 to 48 were distributed to 3 groups through a program in the computer environment without repeating the number (https://www.randomizer.org/). Randomization is provided as follows.
Intervention group 1: 2.8,12,17,18,22,24,25,26,31,33,36,37,40,42,45; Intervention group 2: 1,3,5,10,14,16,19,20,27,28,29,30,32,34,43,44; Intervention group 3: 4,6,7,9,11,13,15,21,23,35,38,39,41,46,47,48;
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
- 28 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborns who are at 28-33 weeks of gestation according to the last menstrual period of the mother,
- •Preterm newborns who are breastfed,
- •Preterm newborns who are clinically stable and enteral feeding started,
- •Preterm newborns who are first enteral nutrition 24 hours after mechanical ventilation,
- •Preterm newborns who are at least 50% of their nutrition provided with enteral nutrition,
- •Free Newborns fed by flow and orogastric tube and with informed consent of the parents will be included in the study.
排除标准
- •Preterm newborns requiring mechanical ventilation,
- •Preterm newborns diagnosed with NEC,
- •Preterm newborns vomiting,
- •Preterm newborns who have abdominal distension,
- •Preterm newborns who have nasal mechanical obstruction,
- •Preterm newborns who have congenital anomalies,
- •Preterm newborns who have gastrointestinal problems such as gastroschisis or congenital diaphragmatic hernia,
- •Preterm newborn who have cerebrovascular disease, apnea episodes, severe neurological disease, were included in the study. will not be included,
- •Preterm newborns who worsen clinically after inclusion in the sample group will be excluded from the study.
研究组 & 干预措施
Intervention Group 2
干预措施: Semi-elevated supine, prone, and right lateral positions (Other)
Intervention Group 3
干预措施: Right lateral, semi-elevated supine, and prone positions (Other)
Intervention Group 1
干预措施: Prone, right lateral, and semi-elevated supine positions (Other)
结局指标
主要结局
Gastric residual volume
时间窗: Preterm newborns whose feedings are every two hours will be monitored for 6 hours and those whose feedings are every three hours will be monitored for 9 hours. Preterm newborns will be monitored for a total of three feedings
Gastric residual volume will be checked manually using a 5 ml syringe prior to feeding. Gastric residue will be excreted or given back in consultation with the doctor according to its amount and color.
Preterm newborn abdominal NIRS value
时间窗: Preterm newborns whose feedings are every two hours will be monitored for 6 hours and those whose feedings are every three hours will be monitored for 9 hours. Preterm newborns will be monitored for a total of three feedings
Average NIRS values will be calculated for periods immediately before, during and after feeding. NIRS values will be recorded by the device, after the monitoring, the picture of the records will be taken from the device.
Fractional oxygen extraction value
时间窗: Preterm newborns whose feedings are every two hours will be monitored for 6 hours and those whose feedings are every three hours will be monitored for 9 hours. Preterm newborns will be monitored for a total of three feedings
Pulse oximeter and NIRS monitor will be used together to determine fractional oxygen extraction.
次要结局
未报告次要终点
研究者
HANDE OZGORU
The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction
Istanbul University - Cerrahpasa