跳至主要内容
临床试验/CTRI/2024/04/065896
CTRI/2024/04/065896招募中不适用

Evaluation and outcome of asymptomatic babies with positive pulse oximetry screening test - a prospective observational study

Shaik Mohammed Munthakheem1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Outcomes of pulse oximetry screening in full term asymptomatic neonates in a tertiary care centre

研究概览

简要总结

Congenital heart diseases (CHDs) are among one of the com- monest congenital malformations encountered in clinical practice and remain an important cause of morbidity and mortality in infants and children.The prevalence of CHD ranges from 8 to 12 per 1000 live births.1,2 With 27 million live births every year, India has a huge burden of children with CHD. However, there are significant problems in the form of poor parental awareness, delayed diagnosis and late referrals to limited and unequally distributed paediatric cardiac care facilities in the public and private sector.3 Critical CHD (CCHD) have been defined in literature as duct- dependent CHD that are life-threatening without treatment in the neonatal period or infancy They include duct-dependent pulmonary defects such as pulmonary atresia with intact ventricular septum, pulmonary stenosis, tetralogy of fallot, total anomalous pulmonary venous return, transposition of the great arteries (TGA), tricuspid atresia, truncus arteriosus or duct-dependent systemic defects such as coarctation of aorta, interrupted aortic arch, hypoplastic left heart syndrome and aortic stenosis.4-6 Life-threatening CCHD form around 10%e 25% of all CHD in the newborn and one third of these neonates are discharged home without a diagnosis.7

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 7.00 Day(s)(—)
性别
All

入选标准

  • All stable and asymptomatic term inborn neonates delivered by normal vaginal delivery/ caesarean.

排除标准

  • Neonates with antenatal ultrasound/ echocardiographic diagnosis of CHD Any neonate requiring Neonatal Intensive Care Unit (NICU) admission Any major congenital malformations.

结局指标

主要结局

Outcomes of pulse oximetry screening in full term asymptomatic neonates in a tertiary care centre

时间窗: Baseline and at discharge

次要结局

  • not applicable(not applicable)

研究者

发起方
Shaik Mohammed Munthakheem
申办方类型
Other [Principal investigator]
责任方
Principal Investigator
主要研究者

Shaik Mohammed Munthakheem

Government medical college

研究点 (1)

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