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CTRI Number  CTRI/2026/01/101471 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparitive study of breastmilk expression manual method and Handpump for milk expression among term babies with poor latch in feeding  
Scientific Title of Study   manual method vs breast pump for breast milk expression in poorly sucking term babies in first postnatal week  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Giraboina Bhavitha 
Designation  post graduate 
Affiliation  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL 
Address  Vinayaka missions medical college and hospital
DEPARTMENT OF PAEDIATRICS
Karaikal
PONDICHERRY
609609
India 
Phone  8247421397  
Fax    
Email  bhavithagiraboina@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Giraboina Bhavitha 
Designation  post graduate 
Affiliation  Vinayaka missions medial college and hospital 
Address  Vinayaka missions medical college and hospital karaikal
department of paediatrics karaikal
Karaikal
PONDICHERRY
609609
India 
Phone  8247421397  
Fax    
Email  bhavithagiraboina@gmail.com  
 
Details of Contact Person
Public Query
 
Name  GIRABOINA BHAVITHA 
Designation  POST GRADUATE 
Affiliation  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL 
Address  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL
DEPARTMENT OF PAEDIATRICS
Karaikal
PONDICHERRY
609609
India 
Phone  8247421397  
Fax    
Email  bhavithagiraboina@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  vinayaka missions medical college 
Address  Vinayaka missions medical college and hospital karaikal 
Type of Sponsor  Private medical college 
 
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 
Bhavitha  Vinayaka missions medical college  Department of Paediatrics vinayaka mission medical college
Karaikal
PONDICHERRY 
8247421397

bhavithagiraboina@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  breast pump for breastmilk expression   Comparision of hand pump for breastmilk expression with manual method for social influences 
Comparator Agent  manual method of breastmilk expression  manual method of breastmilk expression comparision with hand pump showing better efficacy in practical setup 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  POOR SUCKING TERM EARLY NEONATE 
 
ExclusionCriteria 
Details  PRETERM
MOTHER PREVIOUS BREAST SURGERY
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare efficacy of manual breast milk expression with hand pump method and impacts influencing   7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To identify Influences & follow up of infants & comparision between both study groups   7to 14 days 
 
Target Sample Size   Total Sample Size="432"
Sample Size from India="432" 
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)   06/02/2026 
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 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 - NO
Brief Summary  
STUDY OBJECTIVE
To compare breast milk volume between manual breast milk expression and breast pump expression among mothers of term infants with poor latch or poor suck at different time points on postnatal day 2 day 3 and day 4

STUDY DESIGN
Randomized controlled trial

STUDY SETTING
Postnatal ward of a tertiary care hospital

INCLUSION CRITERIA
Mothers of term infants equal to or more than 37 weeks gestation
Infants with poor latch or poor suck
Poor latch or poor suck determined by maternal interview review of lactation consultation and assessment by a study doctor or nurse


EXCLUSION CRITERIA
Mother age less than 18 years
History of breast surgery other than cyst removal
Infants with gestational age less than 37 weeks
Birth weight less than 2500 g



RANDOMIZATION
Eligible mother infant less than 7days were randomly assigned to one of two groups
Manual expression group
Pump expression group

INTERVENTIONS

PRE INTERVENTION PROCEDURE
Initial infant weight recorded using the same weighing scale
Mothers attempted breastfeeding with advice and support from a study doctor or nurse

MANUAL EXPRESSION GROUP
Mothers were taught Marmet hand expression technique
Hand expression performed for 15 minutes in a single supervised session

PUMP EXPRESSION GROUP
Mothers were taught breast pumping technique
Bilateral electric breast pump used for 15 minutes in a single supervised session
Vacuum setting started at 30 mm Hg and gradually increased as tolerated



OUTCOME MEASURES
Expressed breast milk volume measured after expression
Cumulative milk volume calculated
All expressed milk measured using a syringe
Expressed milk fed to infants using syringe cup or spoon
Infants reweighed on the same scale after feeding

QUESTIONNAIRES
Breastfeeding confidence assessment
Breastfeeding related pain assessed in breast lower abdomen back and perineum on a scale of 0 to 10
Assessment of social support for milk expression
Assessment of personal and learning experience of milk expression

FOLLOW UP
Phone follow up at 2 weeks 1 month and 2 months
Assessment of breastfeeding milk expression and formula use
 
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