跳至主要内容
临床试验/NCT02140710
NCT02140710已完成4 期

The Impact of Visceral Osteopathic Treatment on the Meconium Evacuation in Very Low Birth Weight Infants

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2010年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadja Haiden,MD

M.D.

Medical University of Vienna

研究点 (2)

Loading locations...

相似试验