A Retrospective Study of Hypoxemia in Infants After Palliative Neonatal Surgery for Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference.
研究概览
简要总结
Congenital heart disease is a major cause of morbidity and mortality in infants. Many cardiac defects require surgical palliation or repair in the newborn period. The effects of chronic hypoxia on growth and development are unclear. Infants with very severe cardiac defects may undergo surgery in infancy, but often this cardiac surgery can provide only palliation, not correction. As a result, these infants are exposed to a physiology of chronic hypoxia during the neonatal period through infancy, a critical period of growth and development. The optimal oxygen saturations for infants with palliated cardiac defects is unknown. The purpose of this study is to analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference during the first three years of life.
详细描述
We wish to do a retrospective review of clinical data on infants who have undergone surgical palliation for the following cardiac defects over the past five years (from January 1, 2001 through March 31, 2006):
Hypoplastic left heart syndrome Pulmonary atresia Severe pulmonary stenosis.
The patient charts, between the dates of 01.01.2001and 03.31.2006, will be reviewed from Children's Healthcare of Atlanta, Egleston Hospital and the Sibley Heart Center Cardiology clinics of Children's Healthcare of Atlanta.
We will review approximately 180 charts.
We will collect the following information on each patient:
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient charts from 01/01/2001 through 03/31/2006 seen at Children's Healthcare of Atlanta or Sibley Heart Center Cardiology for surgical palliation for Hypoplastic left heart syndrome or surgical palliation for Pulmonary atresia or surgical palliation for Severe pulmonary stenosis
排除标准
- •Those who do not meet inclusion criteria
结局指标
主要结局
Analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference.
时间窗: 5 years
Ongoing data analysis of risk factors for death in the high risk population has revealed that some aspects of the clinical course of these patients which are new to the field. Episodes of decomposition may not have been sudden as previously thought, but may have been preceded by some mild signs of change in cardiovascular status. This may in fact have led to changes in clinical course that were undetected because this was a new clinical finding.
次要结局
未报告次要终点