Evaluation and outcome of asymptomatic babies with positive pulse oximetry screening test - a prospective observational study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Outcomes of pulse oximetry screening in full term asymptomatic neonates in a tertiary care centre
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Day(s) to 7.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All stable and asymptomatic term inborn neonates delivered by normal vaginal delivery/ caesarean.
Exclusion Criteria
- •Neonates with antenatal ultrasound/ echocardiographic diagnosis of CHD Any neonate requiring Neonatal Intensive Care Unit (NICU) admission Any major congenital malformations.
Outcomes
Primary Outcomes
Outcomes of pulse oximetry screening in full term asymptomatic neonates in a tertiary care centre
Time Frame: Baseline and at discharge
Secondary Outcomes
- not applicable(not applicable)
Investigators
Shaik Mohammed Munthakheem
Government medical college
