Observational Study on the Effects of Enteral Feeding and Feeding Methods on Respiratory Pattern as Assessed by Diaphragm Electrical Activity (EAdi) in Very Low Birth Weight Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed
研究概览
简要总结
In this study, we want to see how feeding affects breathing in small premature babies. Using a special feeding tube in the stomach, we can measure how the diaphragm (a large breathing muscle) might be affected by feeding. We also want to see if slowing down the feeding may lessen this effect.
详细描述
Premature babies may have pauses in breathing known as apnea, which may require invasive treatment. The exact cause of apnea is unknown, and may be related to a combination of brain, gut, and lung immaturity.
Research in premature babies suggests that feeding may affect lung functions, but such effects may be lessened if feeds are given at a slower rate. Further research showed that the diaphragm, an important breathing muscle, may be fatigued by a full stomach. We speculate that, in premature babies, feeding might tire the diaphragm, thus impairing lung function and possibly causing apnea.
We plan to study 10 stable premature babies less than 23 weeks and 1.25 kilograms at birth. By inserting a special feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi before and after feeding, we want to directly measure how feeding might affect lung functions. We also want to compare feeding at the usual rate (5-15 minutes) versus a slower rate (90 minutes) to see how their effects on lung functions might differ.
This important study will help us determine the most appropriate treatment for premature babies with apnea related to feeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants >23 weeks gestation
- •Birth weight <1250 grams
- •Not requiring full mechanical ventilation
- •Tolerating full regular bolus feeding for at least 48 hours
排除标准
- •Congenital and acquired problem of the gastrointestinal tract
- •Phrenic nerve injury and/or diaphragm paralysis
- •Esophageal perforation/tracheoesophageal fistula
- •Congenital/acquired neurological deficit and/or seizures
- •Hemodynamic instability
- •Congenital heart disease (including symptomatic patent ductus arteriosus)
- •Undergoing treatment for sepsis or pneumonia
- •Use of muscle relaxants, narcotic analgesics, or gastric motility agents
结局指标
主要结局
Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed
时间窗: Day of study
次要结局
- Change in amount of phasic EAdi before and after an intermittent bolus feed(Day of study)
- Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed(Day of study)
- Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed(Day of study)
- Diaphragmatic fatigue(Day of study)
- Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed(Day of study)
- Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed(Day of study)