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CTRI Number  CTRI/2024/06/068510 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To study Thyroid hormone levels in sick preterm newborn babies 
Scientific Title of Study   A study of Thyroid function tests in sick preterm neonates 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gajapriya A 
Designation  Junior Resident (PG) 
Affiliation  Maulana Azad Medical College 
Address  Department of Physiology, Maulana Azad Medical College. New Delhi

Central
DELHI
110002
India 
Phone  9790262866  
Fax    
Email  priyaterenz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aarti Sood Mahajan 
Designation  Director Professor and HOD 
Affiliation  Maulana Azad medical college 
Address  Department of Physiology, Maulana Azad Medical College. New Delhi

Central
DELHI
110002
India 
Phone  9968604301  
Fax    
Email  aartis_mahajan@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Aarti Sood Mahajan 
Designation  Director Professor and HOD 
Affiliation  Maulana Azad medical college 
Address  Department of Physiology, Maulana Azad Medical College. New Delhi


DELHI
110002
India 
Phone  9968604301  
Fax    
Email  aartis_mahajan@yahoo.co.in  
 
Source of Monetary or Material Support  
Maulana Azad Medical college, Bahadurshah zafar marg New Delhi-110002 India 
 
Primary Sponsor  
Name  Maulana Azad Medical college 
Address  Maulana Azad Medical college Bahadur shah zafar marg New Delhi-110002 India 
Type of Sponsor  Government medical college 
 
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 Gajapriya A  Maulana Azad Medical College and associated Lok Nayak hospital  Intramural unit Department of Neonatology
Central
DELHI 		 9790262866

priyaterenz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAMC New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  7.00 Month(s)
Age To  9.00 Month(s)
Gender  Both 
Details  Preterm infants (28-36 weeks of gestation ) with any morbidity that requires admission and support beyond feeding and observation in warmer. 
 
ExclusionCriteria 
Details  1) infants of mothers with thyroid disease or drugs affecting thyroid levels.
2) visible anomalous/ major congenital malformation at birth.
3) Infants on medications reported to effect thyroid hormone levels.
4) multiple gestations 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean serum level of TSH, FT4, FT3.  0-24hrs and 3-7 days of birth 
 
Secondary Outcome  
Outcome  TimePoints 
1) comparison of serum TSH , FT3, FT4 at different time points.
2) comparison of serum TSH , FT3, FT4 at different gestations
3) Mean of reverse T3 taken on 3-7 day of birth 		 0-24hrs, 3-7 days of birth 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   The current study will be carried out by the department of physiology in association with department of Biochemistry and department of Neonatology , MAMC and associated LN hospital New Delhi
Study will be conducted in the Intramural unit of neonatology department 
The study intends to understand the physiology of the thyroid functions in preterm sick neonates by assessing the serum levels of TSH, FT3, FT4 and RT3.
 
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