FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071269 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to assess the pain relieving effects of Breast milk and a comparison of its effectiveness with that of sugar solution (oral sucrose) and a Placebo (Sterile water) in healthy newborns undergoing a painful procedure.  
Scientific Title of Study   A Randomized controlled trial comparing the analgesic effects of expressed breast milk and oral sucrose during single painful procedures in neonates. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranav Agrawal 
Designation  MD Resident 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No 3, Dept of Pediatrics, BGS GIMS Hospital, BGS Health and Education City Uttarahalli Road Kengeri Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  7038527075  
Fax    
Email  pranav.ag@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Purnima S 
Designation  Professor and Unit Head 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Dept of Pediatrics, BGS Health and Education City Uttarahalli Road Kengeri Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  9902574134  
Fax    
Email  bgsgimspaed@gmail.com  
 
Details of Contact Person
Public Query  
Name  Purnima S 
Designation  Professor and Unit Head 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Dept of Pediatrics, BGS Health and Education City Uttarahalli Road Kengeri Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  9902574134  
Fax    
Email  bgsgimspaed@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Institute of Medical Sciences, BGS GIMS Hospital, BGS Health and Education City Uttarahalli Road Kengeri Bangalore, Karnataka, INDIA, 560060 
 
Primary Sponsor  
Name  Pranav Agrawal 
Address  Dept of Pediatrics, BGS Health and Education City Uttarahalli Road Kengeri Bangalore 
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 Pranav Agrawal  BGS GIMS Hospital  OPD no 4, Room no 18, Dept of Pediatrics, BGS GIMS Hospital, BGS Health and Education City Uttarahalli Road Kengeri Bangalore 560060
Bangalore
KARNATAKA 		 7038527075

pranav.ag@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BGS GIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  clinically stable late preterm and term neonates 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  24% Sucrose Solution  2ml administered once, orally, 2 minutes prior to procedure. 
Intervention  Breastmilk  2ml administered once, orally, 2 minutes prior to procedure. 
Comparator Agent  Sterile Water (Placebo)  2ml administered once, orally, 2 minutes prior to procedure. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All Clinically Stable Neonates of gestational age 35 weeks and above. 
 
ExclusionCriteria 
Details  1. Perinatal Asphyxia
2. Birth trauma
3. Cardiorespiratory instability, suspected or confirmed sepsis or Necrotising Enterocolitis
4. Any Apparent CNS Anomalies
5. Any Previous surgery
6. Maternal use of opioids, sedatives, analgesics
7. NICU Graduates
8. Consent not obtained
9. Use of Paracetamol or any other analgesics in the baby 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of breastmilk in reducing procedural pain in neonates  at Baseline, 30 seconds post procedure, and 5 minutes post procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing the analgesic effects of the three interventions  30 seconds post procedure, 5 minutes post procedure 
Comparison of changes in NIPS Pain Scores and Physiological Parameters between the three interventions  30 seconds post procedure, 5 minutes post procedure 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/07/2024 
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="0"
Months="6"
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pranav.ag@hotmail.com].

  6. For how long will this data be available start date provided 01-11-2024 and end date provided 01-11-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, double blind, parallel group controlled trial comparing the analgesic effects of Breastmilk (Mothers own milk), 24% sucrose solution and a placebo (Sterile water) in healthy newborns undergoing single painful procedures. The primary outcome is to assess he effectiveness of breastmilk in reducing procedural pain in neonates. Secondary outcomes are 1. To compare the analgesic effects of breastmilk, 24% sucrose and a placebo in neonates and 2. To study the variations in physiological parameters (Heart rate, SpO2, Respiratory rate, Mean Arterial Pressure and Mean Crying time) among the three groups.  
Close