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CTRI Number  CTRI/2018/12/016715 [Registered on: 18/12/2018] Trial Registered Prospectively
Last Modified On: 25/09/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective observational 
Study Design  Other 
Public Title of Study   Multicentric, observational study to observe growth in Preterm hospitalized infants . 
Scientific Title of Study   Growth and nutritional biomarkers in preterm infants in NICU – a Multicentric Study in India 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis , Unit No. 10/5 , 10th floor 1858/1, Rajdanga main road

Kolkata
WEST BENGAL
700107
India 
Phone  09831075734  
Fax    
Email  monjorimr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis , Unit No. 10/5 , 10th floor 1858/1, Rajdanga main road

Kolkata
WEST BENGAL
700107
India 
Phone  09831075734  
Fax    
Email  monjorimr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis , Unit No. 10/5 , 10th floor 1858/1, Rajdanga main road

Kolkata
WEST BENGAL
700107
India 
Phone  09831075734  
Fax    
Email  monjorimr@gmail.com  
 
Source of Monetary or Material Support  
Nestle India Limited Nestlé House, Jacaranda Marg M Block DLF City Phase II, National Highway 8 Gurgaon 122 002, India  
 
Primary Sponsor  
Name  Nestle India Limited 
Address  Nestlé House, Jacaranda Marg M Block DLF City Phase II, National Highway 8 Gurgaon 122 002, India 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Kishore Kumar  Cloudnine Hospital  Department of neonatalogy, 1533,9th Main,3rd Jayanagar, Bangalore- 560011, India
Bangalore
KARNATAKA 
8066732259

drkishore@cloudninecare.com 
Dr Apurba Ghosh  Institute of Child Health  Room No. 113, Project Room 11, Biresh Guha Street, Kolkata- 700017
Kolkata
WEST BENGAL 
9830052887

apurbaghosh@yahoo.com 
Dr Ravi Shankar Swamy  Manipal Hospital  Department of neonatalogy, 98, HAL Airport Road, Bangalore -560017
Bangalore
KARNATAKA 
8025024632

raviswamy@manipalhospitals.com 
Prof Dr Neelam Kler  Sir Ganga Ram Hospital  Department of Neonatology Institute of Child Health Sir Ganga Ram Hospital, New Delhi-110060
New Delhi
DELHI 
8447732229

drneelamkler@gmail.com 
Dr Saugata Acharyya  The Calcutta Medical Research Institute  Department of Neonatalogy, 7/2, Diamond Harbour Road Kolkata- 700027
Kolkata
WEST BENGAL 
9830068567

saugata69@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee of Manipal hospitals  Approved 
Ethics Department, Sir Ganga Ram Hospital  Approved 
Institutional Ethics Committee, The Calcutta Medical Research Institute  Submittted/Under Review 
Institutional Ethics Committee,Cloudnine Hospital, Bangalore  Approved 
Institutional Ethics Committee,Institute of Child Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  P05-P08||Disorders of newborn related to length of gestation and fetal growth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Month(s)
Gender  Both 
Details  Stable Preterm AGA infants born between 28 to 34 weeks of gestational age who are on enteral feeding,
Singleton gestation
 
 
ExclusionCriteria 
Details  • On any other clinical study affecting nutritional management during the study period
• Decision to not start minimum enteral feed within 48 hours of birth
• Unable to obtain informed consent from parent (s) or legal guardian prior to the initiation of enteral feeding
• Infants experiencing early onset sepsis (i.e. symptoms requiring antibiotic therapy and confirmed by a positive blood culture occurring before the 3rd day of life).
• Presence of clinically significant congenital heart disease
• Presence of any major congenital malformations, chromosomal abnormality or major gastro intestinal disease known to affect growth
• Liver failure as detected by (if laboratory data is available) aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and direct bilirubin serum values 3-fold higher than reference range.
• Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) determined using cranial ultrasonography, if it is performed.
• Other serious disorders of cardiac/ respiratory/ endocrine/ hematological/ gastrointestinal/ other systems, or serious diseases requiring surgical intervention
• Reasonable potential for early transfer to a non-study institution
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Growth  Observation period for each infant will be the duration of hospital stay after the initiation of first enteral feed after enrollment in to the study.  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Feeding intolerance  Observation period for each infant will be the duration of hospital stay after the initiation of first enteral feed after enrollment in to the study.  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/01/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   The study result will be published in index journal post study completion 
Brief Summary
Modification(s)  
As per directive of ICMR 
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