Skip to main content
Clinical Trials/CTRI/2024/04/065896
CTRI/2024/04/065896RecruitingNot Applicable

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

Shaik Mohammed Munthakheem1 site in 1 country2,000 target enrollmentStarted: April 29, 2024Last updated:

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

Sponsor
Shaik Mohammed Munthakheem
Sponsor Class
Other [Principal investigator]
Responsible Party
Principal Investigator
Principal Investigator

Shaik Mohammed Munthakheem

Government medical college

Study Sites (1)

Loading locations...

Similar Trials