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CTRI Number  CTRI/2024/04/065896 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 28/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluating healthy newborns with failed pulse oximetry screening for different etiologies like critical congenital heart disease,pneumonia,meconium aspiration syndrome etc.,- an observational study 
Scientific Title of Study   Evaluation and outcome of asymptomatic babies with positive pulse oximetry screening test - a prospective observational study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaik Mohammed Munthakheem 
Designation  Senior Resident 
Affiliation  Government medical college 
Address  Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra

Aurangabad
MAHARASHTRA
431001
India 
Phone  9620107364  
Fax    
Email  munthakheem93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr L S Deshmukh 
Designation  Professor and Head 
Affiliation  Government medical college 
Address  Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra

Aurangabad
MAHARASHTRA
431001
India 
Phone  9620107364  
Fax    
Email  deshmukhls@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shaik Mohammed Munthakheem 
Designation  Senior Resident 
Affiliation  Government medical college 
Address  Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra

Aurangabad
MAHARASHTRA
431001
India 
Phone  9620107364  
Fax    
Email  munthakheem93@gmail.com  
 
Source of Monetary or Material Support  
Government medical college (GHATI) Aurangabad,Maharashtra 431001 
 
Primary Sponsor  
Name  Shaik Mohammed Munthakheem 
Address  Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001 
Type of Sponsor  Other [Principal investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shaik Mohammed Munthakheem  Government medical college (GHATI)  Department of Neonatology, 2nd floor, Surgical building, government medical college (GHATI)
Aurangabad
MAHARASHTRA 
9620107364

munthakheem93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Govt Medical college aurangabad ( IEC-GMCA )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Inborn term newborns in the post natal wards will be screened for saturations of the pre ductal and post ductal after 24 hours of life or earlier if being discharged 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  All stable and asymptomatic term inborn neonates delivered by normal vaginal delivery/ caesarean. 
 
ExclusionCriteria 
Details  Neonates with antenatal ultrasound/ echocardiographic diagnosis of CHD
Any neonate requiring Neonatal Intensive Care Unit (NICU) admission
Any major congenital malformations 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Outcomes of pulse oximetry screening in full term asymptomatic neonates in a tertiary care centre  Baseline and at discharge 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable   not applicable 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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

 
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