The Impact of Visceral Osteopathic Treatment on the Meconium Evacuation in Very Low Birth Weight Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- complete meconium evacuation
研究概览
简要总结
Timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function. The time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours). Obstruction of the gastrointestinal tract by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food passage Recent data support the concept that complete rapid evacuation of meconium plays a key role in feeding tolerance . If duration to full enteral feedings is extended, the probability to acquire infections due to intravenous access for parenteral nutrition increases and hospital stay of the infant prolongates. Previously two prospective trials focusing on the problem of delayed meconium evacuation in preterm with different therapeutic pharmacological approaches were published by our group. None of the applied therapies appeared to be effective or had a beneficial effect- quite the contrary one agent (Gastrografin) was supposed to have severe negative side effects. Therefore we were looking for an alternative, non-invasive, holistic solution for the problem of delayed meconium excretion. Osteopathic treatment with the emphasis on the relationship of the structural and functional integrity of the body and with its variety of therapeutic manual techniques seemed to be remedy. Treating the abdomen of premature infants with visceral osteopathic techniques might be more effective to mobilize meconium from small bowel and deep parts of the colon. Therefore we hypothesized that repeated visceral osteopathic treatment accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Minutes 至 24 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •premature infants with a birthweight 1500 gram
排除标准
- •major congenital malformations
- •known gastrointestinal abnormalities
结局指标
主要结局
complete meconium evacuation
时间窗: days up to 100 days of life
Primary outcome parameter was specified as complete meconium excretion. The time to complete meconium evacuation was defined as day of life on which the last meconium was passed. The nursing staff assessed the quality of stools as "meconium" (black, thick, sticky) or "non meconium" by appearance and documented data into the electronic patient documentation system.
次要结局
- Time to full enteral feedings(days up to 100 days of life)
- Introduction of enteral feedings(days up to 100 days of life)
研究者
Nadja Haiden,MD
M.D.
Medical University of Vienna
