Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MaineHealth
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Total hospital length of stay
研究概览
简要总结
The goal of this study is to determine if infants with neonatal encephalopathy will achieve full oral feeds faster after therapeutic hypothermia has completed if they are treated with osteopathic manipulative treatment. The treated infants will be compared to matched historical controls.
详细描述
Infants affected by neonatal encephalopathy (NE) have been shown to have better survival rates and improved long term neurodevelopment following treatment with therapeutic hypothermia. However, a barrier to hospital discharge for these infants is a successful transition from gavage to either breast or bottle feeding.
Often, the factor delaying hospital discharge is slow transition to full oral feeds. Osteopathic manipulative treatment (OMT) helps to effectively stabilize and regulate the autonomic nervous system as well as the cranial nerves important in the sucking and latching reflexes, which may in turn help to ease the transition to full oral feeding. We hypothesize that infants who receive OMT will accelerate the transition to full oral feeds, thus decreasing their overall length of hospitalization compared to historical matched controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 37 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonate > 37 weeks gestational age at birth
- •Neonate been diagnosed with neonatal encephalopathy or hypoxic ischemic encephalopathy and treated with therapeutic hypothermia
- •Neonate with mild to moderate encephalopathy
- •EEG without seizure activity
- •Brain MRI without basal ganglia injury
排除标准
- •Neonate < 37 weeks gestational age at birth
- •Neonate with severe encephalopathy (as defined by Sarnat)
- •EEG demonstrated seizure activity or evidence of status epilepticus during therapeutic hypothermia treatment
- •Brain MRI demonstrating moderate or severe basal ganglia injury
- •Neonate affected by neonatal abstinence syndrome (NAS)
- •Neonate affected by intrauterine growth restriction (IUGR)
- •Neonate born with major congenital anomalies (i.e., cleft palate)
- •Prenatal history of maternal insulin dependent gestational or type 1 diabetes
- •Moribund status (i.e., infants unlikely to benefit from or are not responsive to aggressive life support)
研究组 & 干预措施
OMT group
Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life
干预措施: Osteopathic Manipulative Treatment (OMT) (Procedure)
结局指标
主要结局
Total hospital length of stay
时间窗: 4-6 weeks
Assess the effect of OMT on total hospital length of stay. We will compare infants treated with OMT 1:3 with matched historical controls.
次要结局
- Number of days until full oral feeding is achieved(4-6 weeks)
- Patterns of somatic dysfunction(4-6 weeks)
研究者
Alexa Craig
Neonatal and Pediatric Neurologist
MaineHealth