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CTRI Number  CTRI/2020/12/030109 [Registered on: 29/12/2020] Trial Registered Prospectively
Last Modified On: 28/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical trial to compare the effect of two traditional breast stimulation techniques on quantity of expressed breast milk among mothers of newborn admitted in NICU 
Scientific Title of Study   A study to assess the effect of two traditional breast stimulation techniques on volume of expressed breast milk  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asha K Abraham  
Designation  Tutor  
Affiliation  Army Hospital Referral and Research , New Delhi  
Address  College of Nursing Army Hospital Referral and Research Delhi Cantt
Army hospital Referral and Research Delhi Cantt 110010
New Delhi
DELHI
110010
India 
Phone  7899339164  
Fax    
Email  ashakabraham15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Archana Mourya  
Designation  Professor and HOD Child Health Nursing  
Affiliation  Dutta Meghe Institute of Medical Sciences Deemed to be University  
Address  SRMM CON Dutta Meghe Institute of Medical Sciences sawangi meghe Wardha
SRMM CON Dutta Meghe Institute of Medical Sciences sawangi meghe Wardha
Wardha
MAHARASHTRA
442004
India 
Phone  9422903004  
Fax    
Email  archanatej95@gmail.com  
 
Details of Contact Person
Public Query  
Name  Asha K Abraham  
Designation  Tutor  
Affiliation  Army Hospital Referral and Research , New Delhi  
Address  College of Nursing Army Hospital Referral and Research Delhi Cantt
Army hospital Referral and Research Delhi Cantt 110010
New Delhi
DELHI
110010
India 
Phone  7899339164  
Fax    
Email  ashakabraham15@gmail.com  
 
Source of Monetary or Material Support  
Army Hospital Referral and Research Centre Delhi Cantt 
 
Primary Sponsor  
Name  Asha K Abraham  
Address  College of Nursing Army Hospital Referral and Research New Delhi Delhi Cantt 110010  
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 
Asha K Abraham   Army Hospital Referral and Research Centre  Neonatal Intensive care Unit( First Floor) Department of Peadiatrics Army Hospital Referral and Research centre Delhi Cantt
South West
DELHI 		 917899339164

ashakabraham15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee Army Hospital Referral and Research Centre Delhi Cantt  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  post partum mothers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Warm compress  Warm Compress is given as an adjuvant to breast milk expression by conventional breast pumping. Warm moist compress at a temp between41- 43 degree Celcius will be applied to both breast simultaneously over 10 minutes using a sponge cloth dipped in warm water. The temperature of the water will be maintained with the help of a lotion thermometer.  
Intervention  Breast Massage   Breast massage is used as an adjuvant to breast milk expression by conventional breast pumping. The breast massage is given to both breasts of the participants simultaneously over 10 minutes. The massage is given in steps following each other which includes positioning , Massaging base of the breast tissue, massaging grandular tissue , stroking and shaking . All movements in each steps will be gentle and friction less to ensure no discomfort to the participants. The bassage is provided in gentle movements keeping breast in between palm of the investigator and the stroke is given from base to tip. The steps of interventions are duely validated and found appropriate by the experts in the field .  
Comparator Agent  Not applicable   Not Applicable  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  • Mother of neonate who is admitted in NICU.
• Mother of neonate who is in 3 to 14 days of post partum period.
• Mother of neonate who is exclusively fed on expressed breast milk.
• Mother who is not having any complication during puerperium.
• Mother who is on routine ante natal and post natal drugs such as supplements of iron ,folic acid, calcium, analgesics , and routine antibiotics and obstetric drugs as per hospital policy.
 
 
ExclusionCriteria 
Details  • Mothers diagnosed with breast abscess, mastitis , with breast engorgement, cracked nipple and with the history of any previous breast surgeries.
• Mother taking any special medications such as chemotherapy drugs, ART drugs, immuno suppressants, thyroxine supplements like eltroxin, Insulin and lactation suppression agents.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Volume of expressed breast milk in ml  8 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of breast milk in terms of esterified fat contents assessed by crematocrit method   8 hrs  
breast milk expression experience assessed by breast milk expression experience measure   8 hrs 
Nipple pain   8 hrs  
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   01/01/2021 
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="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
 This study is  a randomised cross over  trial to compare the quantity of breast milk  expressed following   breast simulation using  breast  massage versus  warm  compress  among  88 lactating mothers who are exclusively  expressing  breast milk for newborn admitted to NICU.  Thia study will be conducted in a quaternary hospital in India  and  willl measure the  volume of expressed  breast milk   following two traditional  breast stimulation  techniques as primary outcome .  The  quality of expressed breast milk  expressed  after rwo breast stimulation  techniques will be  compared for the esterified fat content as a secondary outcome  in addition to  maternal outcomes viz  breast milk expression  experience  and nipple pain .  

 
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