Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Infant Attention Task (IAT) measured in seconds
研究概览
简要总结
This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete in-person games and assessments at UW-Madison University Hospital. Children will also take part in an EEG assessment. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child-parent dyads will be recruited to the study.
- •Children 3-24 months with and without a history of a perinatal brain injury (PBI) will be included in this study.
- •Children with PBIs will include:
- •Children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy,
- •Children born at a premature gestational age (born at less than 32 weeks gestational age).
- •Children diagnosed with cerebral palsy
- •Healthy control participants meeting inclusion criteria will include:
- •healthy infants with no prior neurological (brain disorder) history
- •For all parents: the only research inclusion criteria is to be the parent or legal guardian of a newborn with perinatal brain injury or healthy control participant.
排除标准
- •Healthy infants to be included in the control group will not have:
- •a prior history of brain injury
- •a diagnosis of cerebral palsy
- •a history of a neurological disorder
- •prior admission to the Neonatal Intensive Care Unit (NICU)
- •Children with chromosomal abnormalities, genetic syndromes and major congenital malformations will be excluded from both the patient groups and the control group.
- •Parents will have no exclusionary criteria.
研究组 & 干预措施
Children with perinatal brain injury
Children ages 6 months (may be enrolled prior to 6 months) - 18 months who are diagnosed with 1) hypoxic- ischemic encephalopathy, 2) cerebral palsy, and/or 3) were born premature at less than 28 weeks gestational age. (
Healthy Children
Children ages 6 months (may be enrolled prior to 6 months) - 18 months of age with no prior history of a brain and/or cardiac illness early in life.
结局指标
主要结局
Infant Attention Task (IAT) measured in seconds
时间窗: Assessed at the 6,12 and 18 month time-points
A behavioral measure used with infants to assess attentional control and processing. Infants are presented with visual puppet stimuli four distinct "looks", and researchers record looking time, shifts in attention, or habituation patterns. More sustained attention in the early looks followed by habituation to the stimuli in the later looks often indicates better early attentional capacity. Total accumulated looking time to a stimulus in visual preference-type tasks commonly ranges from roughly 15-30+ seconds per trial, depending on the infant's age and the stimulus.
A not B Task
时间窗: Assessed at the 6,12 and 18 month time points
The A-not-B task is a developmental measure of object permanence, working memory, and inhibitory control in infants, requiring them to search for a hidden object after its location is changed. Performance is typically reported as the percentage of correct searches on B trials, with infants 8-9 months averaging 20-40% correct (range 0-100%), 10-11 months averaging 50-70%, and 12-month-olds reaching 75-90%, often near the maximum. Scores vary with delay length and task difficulty.
EEG Power in Delta and Theta Bands
时间窗: Assessed at the 6,12 and 18 month time points
EEG data will be utilized to examine whether neural activity patterns are associated with later executive functioning outcomes. Specific EEG indices will be analyzed as predictors of executive functioning, with lower/higher executive functioning defined by performance on behavioral measures.
次要结局
- Reilly Role Overload Questionnaire(Assessed at the 6,12 and 18 month time points)
- Confusion, Hubbub and Order Scale (CHAOS)(Assessed at the 6,12 and 18 month time points)
- Parenting Daily Hassle (PDH) Scales: Intensity Score(Assessed at the 6, 12 and 18 month time points)
- Parenting Daily Hassle (PDH) Scales: Frequency Score(Assessed at the 6, 12 and 18 month time points)
- Parental Stress Scale(Assessed at the 6, 12 and 18 month time points)
- Early Executive Function Questionnaire: EEFQ(Assessed at the 6, 12 and 18 month time points)
- Bayley Assessment(Assessed at the 6, 12 and 18 month time points)