Prospective Research in Infants With Mild Encephalopathy: the PRIME Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 7
- 主要终点
- Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality.
研究概览
简要总结
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia. The intervention includes: neurologic examination by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the percentage of mild NE infants with evidence of brain injury defined by the presence of at least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period. Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home, death and long-term outcome.
详细描述
Globally, an estimated 1.8 to 7.7 infants per 1000 live term births suffer from perinatal asphyxia, which remains an important cause of neonatal encephalopathy (NE) and neurodevelopmental impairment. Over the last six years, several randomized control trials have demonstrated that prolonged and moderate therapeutic hypothermia (TH) reduces the rate of death or disability at 18 months of age among infants who survived. In these trials, infants were eligible if there was evidence of perinatal hypoxia-ischemia and a moderate or severe degree of encephalopathy on neurological evaluation performed at ≤ 6 hrs of age. However, it has been recognized that the level of NE may change over time. Preliminary and unpublished observations from our group indicated that some infants who were not classified as moderate or severe NE had neurological abnormalities at discharge or evidence of brain injury on MRI performed during the neonatal period. Unfortunately, precise data on the outcomes of this specific population is not clear. Since TH is not offered to this population, the outcomes of infants that do not qualify for TH based on neurological evaluation performed ≤ 6 hrs of life requires a more precise investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with birth weight > or = 1800g and gestational age > or = 36 weeks AND
- •Admission to neonatal intensive care unit (NICU) for possible hypothermia at < or = 6hr of life
排除标准
- •Infants with normal neurological evaluation
- •Major congenital abnormalities
- •Refusal of informed consent
- •Infants who receive passive or active cooling prior to the NICU admission
- •Infants that develop seizures or moderate/severe NE within the first 24 hr of life and are initiated on therapeutic hypothermia after 6 hr of life.
结局指标
主要结局
Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality.
时间窗: 1 month
Evidence of neurological dysfunction/injury/abnormality will be defined by any of these 3 criteria, as follows: 1. MRI = Brain MRI score of pattern of injury (NICHD-NRN) \> 0, 2. aEEG = abnormal background pattern on aEEG (voltage or background pattern) at 6 ± 3 hrs of age. 3. Any abnormality on the neurological at discharge exam.
次要结局
- Length of Hospital Stay(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Percentage of Infants With Seizures(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Mortality Rate(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
研究者
Guilherme Sant'Anna, MD
Associate Professor of Pediatrics
McGill University Health Centre/Research Institute of the McGill University Health Centre