FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/062080 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 25/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [rapid and slow advancement of feeds in preterm IUGR]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   rapid versus slow progression of feeding in less than 34 weeks growth restricted newborns. 
Scientific Title of Study   Rapid versus slow advancement of feeds in early fed preterm iugr neonates 34 weeks:A randomised control trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  mukul chauhan 
Designation  DM Neonatology resident 
Affiliation  maulana azad medical college delhi 
Address  ward no 38 newborn nursery maulana azad medical college bahadur shah zafar marg delhi

Central
DELHI
110002
India 
Phone  8800791731  
Fax    
Email  mukul.chauhan@ymail.com  
 
Details of Contact Person
Scientific Query  
Name  dr Ashish Jain 
Designation  Associate Professor and head of department neonatology 
Affiliation  Maulana azad medical college new delhi 
Address  ward no 38 newborn nursery maulana azad medical college delhi and LNJP hospital

Central
DELHI
110002
India 
Phone  9810694789  
Fax    
Email  neoashish2008@gmail.com  
 
Details of Contact Person
Public Query  
Name  dr mukul chauhan 
Designation  DM Neonatology resident 
Affiliation  Maulana azad medical college new delhi 
Address  ward no 38 newborn nursery maulana azad medical college and LNJP hospital delhi

Central
DELHI
110002
India 
Phone  8800791731  
Fax    
Email  mukul.chauhan@ymail.com  
 
Source of Monetary or Material Support  
maulana azad medical college and LNJP hospital bahadur shah zafar marg delhi 110002 
 
Primary Sponsor  
Name  Maulana azad medical college 
Address  Bahadur Shah Zafar Marg, New Delhi- 110002 
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 
mukul chauhan  maulana azad medical college delhi  ward no 38 newborn nursery maulana azad medical and LNJP hospital college,bahadur shah zafar margnew delhi 110002
Central
DELHI 		 8800791731

mukul.chauhan@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, Maulana Azad Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P051||Newborn small for gestational age, (2) ICD-10 Condition: P051||Newborn small for gestational age,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  rapid vs slow advancement of feeding.  rapid advancement of feeding @ 25ml/kg/day until 150 ml/kg/day achieved. until full feeds are achieved in newborn 
Comparator Agent  slow advancement of feeds.  slow advancement of feeds @15 ml/kg/day. until 150 ml/kg/day reached 
 
Inclusion Criteria  
Age From  7.00 Month(s)
Age To  8.00 Month(s)
Gender  Both 
Details  All preterm IUGR neonates less than 34 weeks with birth weight below the 3rd centile on the Intergrowth 21 charts for the gestational age, admitted to the Neonatal Intensive Care Unit. 
 
ExclusionCriteria 
Details  Exclusion Criteria:
The following neonates will be excluded:
• Antenatally suspected intestinal anomaly
• Lethal congenital anomaly
• Dysmorphic or Syndromic baby
• Neonates needing invasive ventilation
• Inotropic support and on more than 1 ionotrope with instability
• History of extensive resuscitation with apgar at 5 min <5
• All babies with surgical conditions.
• Twins with evidence of Twin-Twin transfusion.
• Intrauterine transfusion or exchange transfusion.
• Any evidence of hydrops
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Estimation of days to attain full feeds defined as 150ml/kg/day in preterm IUGR babies less than 34 weeks fed early where the feeds are rapidly progressed compared to where the feeds are advanced slowly.  time to achieve full feeds in rapid group at 6 days vs slow group at 10 days 
 
Secondary Outcome  
Outcome  TimePoints 
The following will be the secondary objectives investigated in the study, wherein the difference in the rapidly progressing group & the slow advancement of feeds will be estimated.
Incidence of shock during feeding needing any ionotropic support
Incidence of LOS clinical sepsis/ sepsis screen positive / culture positive sepsis
Incidence of NEC. Level II & above
Incidence of FI.
Duration of hospital stay in days
Time to regain birth weight
All-cause mortality.

 		 until 150 ml/kg/day reached or discharge or death 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/10/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mukul.chauhan@ymail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2100?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   There is limited evidence on feeding policy in preterm IUGR severe IUGR newborns. Studies done in preterm IUGR have adapted different definitions of early feeding. Even though recent studies have documented the advantage of early feeding but data with regard to the possibility and advantage of rapid progression in these newborns is negligible. BY this study we want to prove that early and rapid advancement of feeding in this population is beneficial. 
Close