Early growth trends of children under 5 years of age with congenital heart disease who have undergone corrective surgery - a longitudinal study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To evaluate the early growth trends of children with congenital heart disease who have undergone corrective surgery under 5 years of age.
研究概览
简要总结
Congenital heart disease is the most common congenital anomaly found in newborn and nearly 9 to 11 in 1000 newborns are born with cardiac anom- alies in India.[1].Atrial septal defect, ventricular septal defect, patent ductus arteriosus, are the most common congenital heart diseases.[2]
Malnutrition is a common cause of morbidity in such children[3-8]. The extent to which the preoperative nutritional status affects the post op growth is un- known. There may be various factors such as ethnicity, socioeconomic sta- tus, nutritional practices, other cultural and environmental factors that may affect the nutritional status of the child with congenital heart disease[9].
There are various studies showing that corrective surgery shows a significant improvement in growth parameters within 3 months of post surgery{9-11]. However, studies have also shown that postoperative catch-up growth was less pronounced or even absent in 15%-50% of patients depending on the study[8,13]. The factors affecting growth in a child with congenital heart dis- ease may vary worldwide and hence there is a need to assess growth in these children in local conditions. The understanding and prevention of the effect of CHD on patients’ growth and development status in developing countries still needs improvement[11].
This study Is aimed at analysing the early growth trends of children pre and post operatively and factors affecting growth in this region of the country. This study also emphasises the importance of nutritional and growth as- sessment preoperatively so as to predict the early catchup growth post sur- gical correction.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 5.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children under 5 yrs of age with Congenital heart disease fit for corrective surgery 2.Children under 5 yrs of age with failure to thrive with heart disease.
排除标准
- •1.Children under 5 years of age undergoing palliative surgery.
- •2.Children under 5 years of age with congenital heart disease with with other co morbidities like proven chromosomal abnormalities such as downs syndrome, diagnosed with metabolic disorders like galactosemia and hypothyroidism, congenital anomalies that restrict oral feeding like cleft palate and cleft lip.
- •3.Children whose parents donot agree for followup.
结局指标
主要结局
To evaluate the early growth trends of children with congenital heart disease who have undergone corrective surgery under 5 years of age.
时间窗: The study will be completed in the span of 1 year
次要结局
- To identify factors affecting growth in children with Congenital heart disease & analyse the short term effects of corrective surgery.
