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CTRI Number  CTRI/2022/11/047101 [Registered on: 07/11/2022] Trial Registered Prospectively
Last Modified On: 05/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Burden of latent iron deficiency in healthy new-born babies. 
Scientific Title of Study   To determine the incidence of latent iron deficiency in neonates more than 34 weeks with and without risk factors for poor in utero iron status 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Puneeth A 
Designation  Post Graduate student 
Affiliation  Command Hospital (Air Force) 
Address  Department of Pediatrics Command Hospital (Air Force) Old Airport road, Agram post, Bengaluru

Bangalore
KARNATAKA
560007
India 
Phone  8971106141  
Fax    
Email  puneethamaresh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  AJOY KUMAR GARG 
Designation  Associate Professor 
Affiliation  Command Hospital (Air Force) 
Address  Department of Pediatrics Command Hospital (Air Force) Old Airport road, Agram post, Bengaluru

Bangalore
KARNATAKA
560007
India 
Phone  8194827754  
Fax    
Email  ajay4248@gmail.com  
 
Details of Contact Person
Public Query  
Name  Puneeth A 
Designation  Post Graduate student 
Affiliation  Command Hospital (Air Force) 
Address  Department of Pediatrics Command Hospital (Air Force) Old Airport road, Agram post, Bengaluru

Bangalore
KARNATAKA
560007
India 
Phone  8971106141  
Fax    
Email  puneethamaresh@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital Airforce Bangalore 
 
Primary Sponsor  
Name  Command Hospital Airforce Bangalore 
Address  OLD AIRPORT ROAD AGRAM POST BENGALURU - 560 007  
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 Puneeth A  Command Hospital Airforce Bangalore  Room no 3 Department Of Paediatrics 2nd floor, Family Wing, Old Airport Road
Bangalore
KARNATAKA 		 8971106141

puneethamaresh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Command Hospital Air Force  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P018||Newborn affected by other maternalcomplications of pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  All new born babies (NBB) born at CHAF Bangalore with gestational age ≥ 34 weeks 
 
ExclusionCriteria 
Details  1. New born babies with gestational age < 34 weeks.
2. Any maternal h/o hemoglobinopathies or h/o blood transfusion during the current pregnancy.
3. Any maternal h/o third trimester infection/ chorioamnionitis.
4. NBB with chromosomal diseases or severe craniofacial anomalies
5. NBB with bleeding disorders/ congenital anemias/ hemolytic diseases.
6. NBB with obvious iron deficiency (serum ferritin <11 ng/mL).
7. Refusal of consent
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of latent iron deficiency in neonates more than 34 weeks with and without risk factors for poor in utero iron status at birth   From birth to within 72 hours of life 
 
Secondary Outcome  
Outcome  TimePoints 
To study the correlation between maternal iron status and neonatal iron status  at birth 
To compare the iron status of the infant  at birth and 4-6 months of age 
 
Target Sample Size   Total Sample Size="650"
Sample Size from India="650" 
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)   14/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Through email puneethamaresh@gmail.com

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 31-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Iron is an essential micronutrient that plays a significant role in critical cellular functions in all organ systems in all species. Iron plays a fundamental role in neural development. It takes part in the myelination and synaptogenesis processes. The fetus obtains iron from the mother through the placenta and full-term infants are usually born with ample amounts of body iron. However, there are certain conditions which can negatively affect the fetal iron status. These include maternal iron deficiency, prematurity, maternal diabetes mellitus, pre-eclampsia, maternal smoking, and intrauterine growth restriction during pregnancy. These conditions have been associated with decreased iron transfer to the fetus and often lead to in utero iron deficiency. The negative iron balance results in hierarchical loss of tissue iron where iron depletion occurs in the brain before it occurs in the red blood cells. The negative iron status that occurs when brain iron may be depleted but red blood cells are not affected is termed as latent iron deficiency. Latent Iron Deficiency can be defined as serum ferritin level between 11 to 75 ng/ml with normal hemoglobin. Such infants could exhaust their iron stores much earlier and become iron deficient before 6 months of age . Identification of such infants becomes important as in utero LID can result in delayed neuronal maturation and abnormal neurological outcomes during childhood.

As very little is known about the incidence of in utero LID and the risk factors associated with it, we are aiming to determine the incidence of LID in pregnancy with and without risk factors for poor in utero iron status through our study.


  
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