Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Asthma
研究概览
简要总结
Despite improved survival of extremely premature infants in recent decades, neonatal intensive care unit (NICU) graduates are diagnosed with asthma, sleep disordered breathing (SDB) in childhood, and neurodevelopmental impairments (NDI) at significant rates, disproportionate to their term peers. Early detection and intervention are critical to mitigate the impact of these impairments. Mechanisms leading from premature birth to these undesirable outcomes remain unclear, and accurate prognostic measures are lacking.
This study wants to learn if these problems are related to certain patterns of breathing that babies had while they were in the NICU.
详细描述
Asthma, SDB, and NDI are common consequences of preterm birth with significant impact on child and family quality of life and public health. To date, the mechanisms leading to these outcomes remain unclear, and improvements in neonatal care have not improved these outcomes. While early detection and intervention can reduce the burden of these outcomes, methods for early identification of infants destined for these morbidities is currently lacking. Utilizing the Pre-Vent cohort to investigate potential underlying causes and identify predictors for these conditions as we propose here is essential to inform future prevention and intervention strategies that promote optimal health and development.
Recent compelling data indicate that early postnatal intermittent hypoxemia (IH) events may play a role in undesirable outcomes. Early postnatal IH events in extremely preterm infants are associated with bronchopulmonary dysplasia (BPD), asthma medication at 2 years, and NDI at 18 months. The ability of IH to perturb maturation of long-term respiratory control has been demonstrated in neonatal rodents consistent with preterm infants being at heightened risk for childhood SDB. Although evidence is emerging that IH events are linked to poor outcomes in premature infants, the specific relationship between distinct IH patterns (e.g. duration, timing, frequency, and nadir) and longer-term respiratory and neurologic function remains to be elucidated.
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
- 30 Weeks 至 83 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in any Institutional Review Board (IRB) protocol of the Pre-Vent Study that had signed consent, or in any IRB protocol of the Pre-Vent Study that authorized re-contact for future research
- •Born <29 weeks gestational age
- •Age at enrollment less than 7 years old
排除标准
- •Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason
- •Subject had no physiological data recorded as part of Pre-Vent
- •Lack of regulatory approval from local IRB or Department of Children and Family Services (DCFS) to recontact subjects
- •Adopted by non-consenting family
- •Parent refused further contact, prior to approach for Post-Vent
- •Infant enrolled in Pre-Vent at Washington University St Louis, which is not a Post-Vent participating site.
结局指标
主要结局
Asthma
时间窗: 5 years ± 6 months of age
Doctor diagnosed asthma as assessed in the International Study on Asthma and Allergies in Childhood questionnaire (ISAAC)
Sleep Disordered Breathing (SDB)
时间窗: 5 years ± 6 months of age
Sleep-Related Breathing Disorder (SRBD) score \>= 0.33. Scores \>0.33 are considered positive and suggestive of high-risk for a pediatric sleep-related breathing disorder.
Neurodevelopmental Impairment (NDI)
时间窗: 5 years ± 6 months of age
≤10th percentile in any of the National Institutes of Health (NIH) Toolbox domains may indicate neurodevelopmental impairment.
次要结局
- Motor Function(5 yr. (+/- 6 months))
- Sensory Outcomes: Odor Identification(5 yr. (+/- 6 months))
- Respiratory Symptoms(6 mo through 5 yr. +6 months)
- Medically attended respiratory illnesses(6 mo through 5 yr. +6 months)
- Asthma Severity(5 yr. (+/- 6 months))
- Sleep Disordered Breathing (SDB)(5 yr. (+/- 6 months))
- Gross Motor Function(5 yr. (+/- 6 months))
- Cognitive Function(5 yr. (+/- 6 months))
- Executive Function(5 yr. (+/- 6 months))
- Sensory Outcomes: Acuity(5 yr. (+/- 6 months))
- Pediatric Quality of life(5 yr. (+/- 6 months))
- Health utilization(6 mo through 5 yr. +6 months)
- Medications(5 yr. (+/- 6 months))
- Doctor Diagnosed Asthma(6 mo through 5 yr. +6 months)
- Asthma Severity: Modified Composite Asthma Severity Index(MCASI)(6 mo through 5 yr. +6 months)
- Asthma Severity: Global Initiative for Asthma criteria (GINA)(6 mo through 5 yr. +6 months)
- Social, Emotional and Behavioral Outcomes(5 yr. (+/- 6 months))
- Respiratory Symptoms(5 yr. (+/- 6 months))
- Medically attended respiratory illnesses(5 yr. (+/- 6 months))
- Health utilization(5 yr. (+/- 6 months))