| 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
|
|
|
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
|
|
|
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 |