The TIME STUDY: A Randomized Controlled Trial of Therapeutic Hypothermia for Infants With Mild Encephalopathy in California
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 10
- 主要终点
- Alberta Infant Motors Scale (AIMS)
研究概览
简要总结
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6 hours of age. Neurodevelopmental outcome will be assessed at 12-14 months of age. The study will enroll 68 neonates randomized to therapeutic hypothermia or normothermia across 5 centers in California.
详细描述
The TIME study is a multi-center randomized, controlled trial of Therapeutic Hypothermia (TH) (33.5°C ± 0.5° for 72 hours) versus normothermia using targeted temperature management, initiated within 6 hours after birth in term neonates with Mild Hypoxic-Ischemic Encephalopathy (HIE). Mild encephalopathy will be identified using the 6 component modified Sarnat exam as in the Neonatal Research Network of the National Institute of Child Health and Human Development trials of TH for moderate-severe encephalopathy and will be expanded to include features of mild encephalopathy. Eligible subjects must demonstrate ≥ 2 exam abnormalities (mild, moderate, severe) but without evidence of moderate-severe encephalopathy (≥ 3 moderate or severe features). The primary outcome is neurodevelopmental outcome at 12-14 months of age. Secondary outcomes include evaluating the safety profile of therapeutic hypothermia in patients with Mild HIE. Therapeutic hypothermia is well tolerated and did not demonstrate serious safety concerns when evaluated in multiple large studies of neonates with moderate-severe HIE. It is now being applied by some practitioners to neonates with Mild HIE without systematic evidence of benefit or potential harm. This data will be necessary in order to develop and larger trial of efficacy to be determined at 2 years of age.
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
- Single (Outcomes Assessor)
盲法说明
Assessors of neurodevelopmental outcome at 12-14 months of age will be blinded to the allotted treatment group
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
- 未提供
排除标准
- •Patients < 36 0/7 weeks birthweight < 1800gm; congenital or chromosomal anomaly associated with abnormal neurodevelopment or death; patients with moderate or severe HIE (by Sarnat exam or presence of clinical or electrographic seizures) identified within 6 hours after birth; core body temperature < 34°C for more than 1 hour prior to randomization.
结局指标
主要结局
Alberta Infant Motors Scale (AIMS)
时间窗: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age
Alberta Infant Motors Scale (AIMS) will be assessed at 12-14 months of age. The AIMS score is determined by assessment of 4 positions and scoring the least and most mature position identified. The score is converted to a percentile for age with those in the 5th to 25th percentile identified as suspicious motor development and those with a score corresponding to \< 5th percentile being identified as abnormal motor development.
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
时间窗: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be assessed at 12-14 months of age. The mean score for a 12 month old normally developing infant is 109 with a standard deviation of 16.5. Higher scores are associated with normal development.
次要结局
- Percentage of participants with sinus bradycardia(72 hours)
- Percentage of participants thrombocytopenia(72 hours)
- Percentage of patients who require intubation and mechanical ventilation(72 hours)
- Percentage of participants diagnosed with seizures(During initial hospital stay up to 30 days)
- Age at initiation of feeds(During initial hospital stay up to 30 days from date of admission)
- Age at full enteral feeds(During initial hospital stay and up to 30 days from date of admission)
- Percentage of participants who require feeding assistance at discharge(At time of discharge from hospital, up to 30 days from admission)
- Percentage of patients with need for central line(72 hours)
- Percentage of participants with Persistent Pulmonary Hypertension (PPHN)(72 hours)
- Percentage of participants exposed to sedating or analgesic medications(72 hours)
- Percentage of participants exposed to inotropic agents(76 hours)
- Percentage of participants with fat necrosis and hypercalcemia(From study entry to day of hospital discharge, up to 30 days from admission)
- Percentage of participants discharged on anti-convulsant medications(At time of discharge from hospital, up to 30 days from admission)
- Count of participants with brain injury on MRI(At time of discharge from hospital, up to 30 days from admission)
- Length of Hospital Stay(At time of discharge from hospital, up to 30 days from admission)
- Percentage of participants breastfeeding at discharge(At time of discharge from hospital, up to 30 days from admission)
- Percentage of participants with death and/or hospice at discharge(At time of discharge from hospital, up to 30 days from admission)
研究者
Sonia Bonifacio
Clinical Associate Professor
Stanford University