Using Osteopathic Manipulative Medicine on Preterm Infants in the Neonatal Intensive Care Unit to Reduce Neuromotor Developmental Delays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Test of Infant Motor Performance (TIMP)
研究概览
简要总结
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
详细描述
Hypothesis
High risk preterm infants born <34 weeks of gestation who receive OMM, compared to the standard supportive care, will have improved neuromotor development scores on the TIMP.
Specific Aims and Objectives:
Primary aim: To determine the difference in TIMP scores between infants who receive OMM and those who receive only standard neonatal intensive care unit (NICU) care.
Secondary aims:
- To compare length of stay between infants who receive OMM and those who receive only standard NICU care.
- To compare growth parameters including weight, length, and head circumference, (both means and Z scores) prior to discharge between infants who receive OMM and those who receive only standard NICU care.
- To compare percentage of subjects requiring nasogastric, orogastric, or gastrostomy tube feeds at discharge between infants who receive OMM and those who receive only standard NICU care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The individual performing the developmental assessment will be unaware of study arm assignment
入排标准
- 年龄范围
- 1 Day 至 14 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •23 0/7- 33 6/7 weeks' gestational age (GA) at birth, ≥28 0/7 weeks' GA at time of consent
- •stable enough to tolerate gentle manipulation
排除标准
- •> 33 6/7 weeks' GA at birth
- •known congenital and genetic abnormalities affecting neurodevelopment
- •known conditions requiring surgical intervention
- •severe intracranial hemorrhage or other severe neurologic complications
- •parents unable to read and understand English
结局指标
主要结局
Test of Infant Motor Performance (TIMP)
时间窗: At approximately 36 weeks' corrected gestational age
Standardized, validated assessment of risk for developmental delay; expected range: 20 - 90 with higher scores indicating less risk for developmental delay
次要结局
- Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge(at NICU discharge, assessed up to 1 year)
- Length of stay(At NICU discharge, assessed up to 1 year)
- Growth parameters - weight(at 36 weeks' corrected gestational age and discharge)
- Growth parameters - length(at 36 weeks' corrected gestational age and discharge)
- Growth parameters - head circumference(at 36 weeks' corrected gestational age and discharge)
研究者
Ronnie Guillet
Professor of Pediatrics (Neonatology)
University of Rochester