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CTRI Number  CTRI/2023/12/060551 [Registered on: 20/12/2023] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Early total versus gradual enteral feeding in very preterm neonates]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of early total versus gradual introduction of enteral feeds on very preterm neonatal outcomes 
Scientific Title of Study   Effect of early total versus gradual enteral feeding on short term outcomes in neonates less than 32 weeks of gestation 
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 N D Vaswani 
Designation  Professor Paediatrics 
Affiliation  Pt. B D Sharma Post Graduate Institute of Medical Sciences, Rohtak 
Address  Professor in department of paediatrics, Head of unit 14/3, Pt. B. D. Sharma Post Graduate institute of Medical Sciences,Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9466676863  
Fax    
Email  ndvaswani@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N D Vaswani 
Designation  Professor Paediatrics 
Affiliation  Pt. B D Sharma Post Graduate Institute of Medical Sciences, Rohtak 
Address  Professor in department of paediatrics, Head of unit 14/3, Pt. B. D. Sharma Post Graduate institute of Medical Sciences,Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9466676863  
Fax    
Email  ndvaswani@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ritika Singh 
Designation  Post Graduate Resident 
Affiliation  Pt. B D Sharma Post Graduate Institute of Medical Sciences, Rohtak 
Address  Room number 77, Ganga Girls Hostel, Pt. B D Sharma, Post Graduate Institute of Medical Sciences, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9810210522  
Fax    
Email  ritika16singh@gmail.com  
 
Source of Monetary or Material Support  
Pt. B. D Sharma Post Graduation Institute of Medical Science Rohtak 
 
Primary Sponsor  
Name  Dr N D Vaswani 
Address  Professor in Department of Paediatrics, Head of Unit 14/3, Pt. B. D Sharma Post Graduation Institute of Medical Science Rohtak Haryana 124001  
Type of Sponsor  Other [Self] 
 
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 Ritika Singh  Pt. B. D Sharma Post Graduation Institute of Medical Science Rohtak   Department of Paediatrics and Department of Neonatology, Pt. B. D Sharma Post Graduation Institute of Medical Science Rohtak Haryana 124001
Rohtak
HARYANA 		 9810210522

ritika16singh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee Pt. B. D. Sharma PGIMS Rohtak   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 
Comparator Agent  CONTROL GROUP  Enteral feeds will start with 20mL/kg on day 1, then advanced by 20 mL/kg per day on second day onwards until the infant reaches full enteral feeds while simultaneously decreasing the fluid requirement 
Intervention  TEST GROUP  Early full enteral feeds, i.e feeds commenced from day 1 of life 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  90.00 Day(s)
Gender  Both 
Details  Very preterm neonates with gestational age 28 to 31+6 (after taking informed parental consent) weeks fulfilling the following criterion
1.Hemo dynamically stable neonates
2.No abdominal distention 
 
ExclusionCriteria 
Details  1. Gestational age less than 28 weeks
2. Severe birth asphyxia
3. Major gastro intestinal congenital anomalies
4. Absence /reversed end diastolic flow in the umbilical artery on antenatal USG
5. Respiratory support beyond nasal prongs, CPAP, NIMV
6. Shock 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The time to reach full feeds in early total enterally fed as compared to gradually fed newborns   Any time during the study period 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the incidence of sepsis, Necrotising enterocolitis(NEC), episodes of feed intolerance, duration of hospital stay, anthropometric indices, till discharge in the two feeding groups  Any time during the study period 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 3/ Phase 4 
Date of First Enrollment (India)   28/12/2023 
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)   Not Yet Recruiting 
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 - NO
Brief Summary
Modification(s)  

The present study shall be conducted in Department of Paediatrics and Department of Neonatology, Pt. B . D. Sharma, Post Graduate Institute of Medical Sciences, Rohtak. Study participants shall be taken from neonatal intensive care unit Pt B D Sharma PGIMS Rohtak. Very preterm neonates (Gestational age 28 to 31+6 weeks) who fulfil the inclusion criteria will be recruited for the study Randomisation will be done by block randomisation technique using computer generated block randomisation. The outcome would be assessed in accordance to the day of attaining full feeds in very preterm neonates(28 to 31+6 weeks) and also determine the all cause mortality between the two feeding groups. Secondarily this study aims to assess the incidence of sepsis, Necrotising enterocolitis(NEC), episodes of feed intolerance, duration of hospital stay, anthropometric indices, till discharge in preterm neonates fed enterally versus neonates fed gradually.

 
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