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CTRI Number  CTRI/2017/11/010577 [Registered on: 21/11/2017] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutrition]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of growth in VLBW neonates randomised to 2 hourly and 3 hourly feeding intervals 
Scientific Title of Study   A randomised control trial to compare growth velocity in VLBW neonates (1-1.5 kg) fed at 2 hourly and 3 hourly intervals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avadhesh Joshi 
Designation  Senior PG Registrar 
Affiliation  Christian Medical College 
Address  Dr. Avadhesh Joshi Department of Neonatology, ISSCC building, CMC, Vellore Tamil Nadu, India

Vellore
TAMIL NADU
632004
India 
Phone  8890955794  
Fax    
Email  joshi.kmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Avadhesh Joshi 
Designation  Senior PG Registrar 
Affiliation  Christian Medical College 
Address  Dr. Avadhesh Joshi Department of Neonatology, ISSCC building, CMC, Vellore Tamil Nadu, India

Vellore
TAMIL NADU
632004
India 
Phone  8890955794  
Fax    
Email  joshi.kmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Sridhar 
Designation  Professor & Head 
Affiliation  Christian Medical College 
Address  Department of Neonatology, ISSCC building, CMC, Vellore Tamil Nadu, India

Vellore
TAMIL NADU
632004
India 
Phone    
Fax    
Email  neonat@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
FLUID research grant, IRB, CMC Vellore 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Christian Medical College Ida Scudder Road, Vellore - 632004 Tamil Nadu, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avadhesh Joshi  Christian Medical College  Department of Neonatology, ISSCC building, 3rd floor, CMC, Vellore
Vellore
TAMIL NADU 
8890955794

joshi.kmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Very low birth weight babies (1-1.5 kg),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2 hourly feeding interval  Babies will be given feed at 2 hourly interval till weight of baby reaches 1.8kg 
Intervention  3 hourly feeding interval  Babies will be given feed at 3 hourly interval till weight of baby reaches 1.8kg 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  To compare weight gain velocity (gm/kg/day) in VLBW babies receiving 2 hourly v/s 3 hourly feeds 
 
ExclusionCriteria 
Details  1) Infants with major congenital anomalies, surgical conditions, conditions where feed intolerance is anticipated.
2) Lack of Consent
3) Clinician decision regarding poor chances of survival
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare weight gain velocity (gm/kg/day) in VLBW babies receiving 2 hourly v/s 3 hourly feeds  weight of baby 1.8kg 
 
Secondary Outcome  
Outcome  TimePoints 
1) Time to reach birth weight
2) Time to reach full feeds (200 ml/kg/day)
3) Incidence of feed intolerance, sepsis, probable sepsis, NEC, hypoglycaemia, hyperbilirubinemia, apnea
4) Duration of hospitalisation
5) Duration of phototherapy
6) Anthropometric measurements: head circumference velocity, length gain velocity
7) Duration of central venous lines and incidence of CLABSI
8) Total time spent by nurses on feeding
 
weight of baby 1.8kg 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2017 
Date of Study Completion (India) 24/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/08/2019 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Adequate nutrition plays an important role in survival, growth and development of preterm infants. Nutrition in preterm infants can be given via enteral or parenteral route. Parenteral route has complications of vascular catheterisation, sepsis, fasting and adverse effects of nutrition. The cost is also increased with use of TPN. Enteral feeding is also beneficial as it improves gastro-intestinal motility, increases release of gastro-intestinal hormones which have trophic effects and leads to decreased feed intolerance. Enteral feeding practices vary between different neonatal units. Preterm neonates have lack of co-ordination between sucking, swallowing and breathing hence gavage feeding is started. They are arbitrarily given bolus feeding at fixed intervals or given continuous feeds. Bolus feeding may be more physiological as it brings about more natural surges in intestinal hormones. Bolus feeding is also given at different intervals(1 hourly, 2 hourly, 3 hourly). There is no consensus on what feed interval to be followed in preterm VLBW infants. In our nursery, 2 hours feeding regimen is routinely followed with few babies being shifted to 1 hourly, 3 hourly or continuous feeds as per clinician’s decision. This study is designed to evaluate the weight gain velocity of babies receiving 3 hourly feeds as compared to 2 hourly feeds.

 
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