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CTRI Number  CTRI/2018/05/014230 [Registered on: 30/05/2018] Trial Registered Retrospectively
Last Modified On: 03/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare breastmilk and glucose in reducing pain in newborn during needle prick. 
Scientific Title of Study   Efficacy of oral 25%Dextrose and Expressed breast milk on pain score among neonates undergoing venipuncture  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raima Lukas 
Designation  MSc Nursing trainee officer 
Affiliation  College of Nursing, AFMC 
Address  Department of Child Health Nursing College of Nursing Armed Forces Medical College Pune-40
D6/6 Salunke Vihar NIBM Road Pune
Pune
MAHARASHTRA
411040
India 
Phone  8848858023  
Fax    
Email  raimalukas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Lt Col Kabita Jana 
Designation  Associate Professor 
Affiliation  College of Nursing, AFMC 
Address  Department of Child Health Nursing College of Nursing Armed Forces Medical College Pune - 40
Lt Col Kabita Jana (Guide) Associate Professor Department of Child Health Nursing College of Nursing Armed Forces Medical College Pune - 40 email id - jana.kabita@yahoo.in
Pune
MAHARASHTRA
411040
India 
Phone  8848858023  
Fax    
Email  jana.kabita@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Raima Lukas 
Designation  MSc Nursing trainee officer 
Affiliation  College of Nursing, AFMC 
Address  Department of Child Health Nursing College of Nursing Armed Forces Medical College Pune-40

Pune
MAHARASHTRA
411040
India 
Phone  8848858023  
Fax    
Email  raimalukas@gmail.com  
 
Source of Monetary or Material Support  
Raima Lukas(Researcher) and Educational Institution College of Nursing Armed Forces Medical College Pune - 40 
 
Primary Sponsor  
Name  Raima Lukas 
Address  College of Nursing Armed Forces Medical College Pune - 40 
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 
Raima Lukas  Command Hospital Pune - 40  Paediatric OPD and Postnatal ward
Pune
MAHARASHTRA 		 8848858023

raimalukas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Research Cell and Institutional Ethical Committee, Armed Forces Medical College, Pune - 40  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Newborn babies requiring venipuncture for blood sampling,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Expressed Breast Milk group  2 ml Expressed Breast Milk From the babys mother 
Intervention  Oral 25% Dextrose group  2ml commercially available 25 dextrose 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates >37 week gestations who require venipuncture for blood sampling and who are on oral feeds. 
 
ExclusionCriteria 
Details  1. Neonates who had suffered perinatal asphyxia (Apgar score <5 at 5 minutes), congenital malformations and those on analgesics or sedatives.
2. Neonates with metabolic disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Neonatal Infant Pain Score  2 min after administration of test solution and during venipucture  
 
Secondary Outcome  
Outcome  TimePoints 
crying time
Heart rate 		 6 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/08/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A randomised control trial to assess the efficacy of oral 25% dextrose and expressed breast milk  on pain score among neonates undergoing venipuncture. A sample size of 40 will be taken and randomised into two group. The randomisation of the sample will be done by computer generated chit method. Chits will be numbered and kept in opaque sealed envelope.  The neonates requiring venipuncture will be taken to a quiet room. It will be ensured that time interval between the procedure and previous breast milk intake is at least one hour.  Baseline respiratory rate of the baby will be recorded. 2 ml of test solution will be administered to the baby’s mouth. All venipunctures will be done with 23-gauge needle 2 minutes after the test solution is administered. All venipunctures will be done by same individual who has adequate experience in neonatal care to minimize variation in pain during venipuncture. The video graph of the baby will be taken for later analysis. The response to pain during this period will be recorded and subsequently analysed from the video by a single observer. The primary outcome of the study will be the NIPS score.

 
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