Neurodevelopmental Outcomes and Growth in Infants With Congenital Gastrointestinal Anomalies Requiring Neonatal Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Growth
研究概览
简要总结
Infants with congenital gastrointestinal anomalies (CGIA) experience multiple physiologic stressors, including neonatal surgery, early in life during an essential time of growth and development. Early physiologic stressors such as inadequate nutrition have been linked to altered growth patterns and neurodevelopmental delays later in life. In other groups of at-risk infants, early body composition measurements can be used as predictors of long-term health outcomes more so than weight and length alone. The primary objective of this study is to determine if body composition changes in early life are predictive of neurodevelopmental outcomes among infants with CGIA. The secondary objective is to determine if infants with CGIA have altered body composition over time when compared with healthy infants. The investigators propose a prospective, observational study of infants with CGIA, including detailed chart review, body composition measurements, and neurodevelopmental testing at follow-up. If a correlation between body composition measurements and neurodevelopmental outcomes is established in this population, the addition of body composition measurement to standard of care in the neonatal intensive care unit and in follow-up care could allow for further optimization of overall health and development of this vulnerable pediatric population through earlier detection of growth alterations and informed interventions.
详细描述
Infants with congenital gastrointestinal anomalies (CGIA) including gastroschisis, omphalocele, esophageal and bowel atresias, tracheoesophageal fistulas, Hirschsprung's disease, and congenital diaphragmatic hernias, account for ~7 in 10,000 live births. Early in life, these infants undergo major surgery under general anesthesia followed by a prolonged period of inadequate nutrition, exposure to post-operative pain medications and antibiotics, and parental separation. Despite exposure to these risk factors for future growth failure and neurodevelopmental delay, growth and neurodevelopmental outcomes have not been well described in this group of at-risk infants. Preliminary findings in preschool-age children with CGIA suggest that these children have slower speed of processing compared to healthy children and that increased fat-free mass (FFM) at preschool age is associated with higher cognitive test scores. However, no studies to date have described the longitudinal relationship between growth, body composition, nutrition, inflammation, and neurodevelopmental outcomes in infants with CGIA. To address this research gap, the investigators propose to conduct a prospective cohort study enrolling infants with CGIA to measure their growth and development over time. Infant growth and body composition will be measured at or near term and at 4 months corrected age.
The investigators hypothesize that infants with CGIA will undergo a period of rapid catch-up growth early in life, and infants who demonstrate better catch-up growth will have better neurodevelopmental outcomes compared to infants that do not experience catch-up growth. At 4 months corrected age, early neurologic outcomes will be measured using event related potentials (ERP). Clinical information including nutrient intake, inflammatory markers, and medications received will be gathered throughout the neonatal intensive care unit (NICU) hospitalization to assess the impact physiologic stressors have on changes in body composition and cognitive outcomes.
The objective of this study is to determine the impact of early nutrition, inflammation, physiologic stress, growth, and body composition on later neurodevelopmental outcomes in infants requiring neonatal surgery for CGIA.
Specific aims include:
Aim 1. To determine if infants with CGIA requiring neonatal surgery have altered body composition growth patterns compared to healthy infants.
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
- 0 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Late preterm (at or above 35 weeks gestation) and term infants
- •Admitted to the NICU
- •Diagnosed with congenital gastrointestinal anomalies, defined as gastroschisis, omphalocele, esophageal and bowel atresias, tracheoesophageal fistulas, Hirschsprung's disease, or congenital diaphragmatic hernias.
排除标准
- •Infants born before 35 weeks gestation
- •Infants with cardiac defects requiring intervention
- •Infants with known chromosomal abnormalities that affect growth or cognition
- •Infant born to families that are non-English speaking due to lack of interpreter services available
结局指标
主要结局
Growth
时间窗: At term equivalence and at 4 months corrected age
Anthropometric and body composition measurements
次要结局
- Neurodevelopment(At 4 months)