| CTRI Number |
CTRI/2026/04/107843 [Registered on: 08/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| 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
|
To study the effect of breastmik milk extraction frequency on secondary lactation and exclusive breastfeeding rate |
|
Scientific Title of Study
|
Effect of frequency of breastmilk extraction during initial postnatal days on onset of secreatory activation of lactation and exclusive breastfeeding rate |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garvita sharma |
| Designation |
junior resident |
| Affiliation |
king george medical university |
| Address |
department of pediatrics
king george medical university
lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7055956330 |
| Fax |
|
| Email |
drgarvitasharma20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SN Singh |
| Designation |
Professor and Head |
| Affiliation |
king george medical university |
| Address |
Department of pediatrics
king george medical university
lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415196707 |
| Fax |
|
| Email |
snsingh@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr SN Singh |
| Designation |
Professor and Head |
| Affiliation |
king george medical university |
| Address |
Department of pediatrics
king george medical university
lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415196707 |
| Fax |
|
| Email |
snsingh@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
| king George medical university |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
kgmu, lucknow, |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Garvita sharma |
Queen marry hospital |
queen marry hospital, post natal ward, kgmu chowk, lucknow
Lucknow
UTTAR PRADESH |
07055956330
drgarvitasharma20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
These are the healthy mothers who have given birth to the baby |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mother neonate dyad |
increasing the breast milk extraction frequency to more than 10 times a day |
| Comparator Agent |
mother neonate dyad |
mothers having the breast milk extraction frequency of 8 to 10 times a day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
• Late preterm (32 weeks and healthy), Term singleton infants (more than 37 weeks), Apgar more than 7 at 5 min, mothers intending to breastfeed, initiation of first breastfeed within first hour of birth.
• Written Informed consent from parents/guardian
|
|
| ExclusionCriteria |
| Details |
1. Major congenital anomaly,
2. Sick neonates requiring NICU admission
3. Maternal contraindication to breastfeeding (HIV where formula feeding indicated, Active TB on treatment as per local policy, etc.)
4. Not giving consents
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no difference in onset of secretary activation of lactation and exclusive breastfeeding rate at 1, 3, and 6 months in late preterm and term newborn infant-mother dyad whether breastmilk extraction frequency is more than 10 times or 8-10 times in 24 hours during early postnatal days |
At baseline, 1 months and 3 months and 6 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
20/04/2026 |
| 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="2"
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
|
This randomised control trial aims to investigate the effect of frequency of breastmilk extraction on secondary activation of laction and breast feeding rate. By systematically collecting and analyzing data on maternal status, and relevant biochemical markers following secreatory activation of lactation , this research seeks to provide critical insights into the time duration of onset of secondary activation of lactation .The findings are expected to contribute to a more evidence-based understanding of onset of secreatory activation of lactation, ultimately guiding improved maternal and neonatal outcomes |