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CTRI Number  CTRI/2025/02/079892 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Latch score as a tool to promote breastfeeding 
Scientific Title of Study   LATCH score as a tool to predict Exclusive breastfeeding at six month post partum- A cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kusum chandrakar 
Designation  Junior resident 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Pediatrics Rohilkhand medical college and hospital pilbhit bypass road bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  7987023930  
Fax    
Email  chandrakarkusum508@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti lata rai 
Designation  Professor  
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Pediatrics, Rohilkhand medical college and hospital pilbhit bypass road bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8057383699  
Fax    
Email  dr.plr21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti lata rai 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Pediatrics, Rohilkhand medical college and hospital pilbhit bypass road bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8057383699  
Fax    
Email  dr.plr21@gmail.com  
 
Source of Monetary or Material Support  
Dr kusum chandrakar 
 
Primary Sponsor  
Name  Dr kusum chandrakar 
Address  Rohilkhand medical college and hospital pilbhit bypass road bareilly 
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 kusum chandrakar  Rohilkhand Medical college and hospital  Department of Pediatrics Rohilkhand medical college and hospital philbhit bypass road, bareilly
Bareilly
UTTAR PRADESH 
7987023930

chandrakarkusum508@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committe, RMCH, Bareilly  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O779||Labor and delivery complicated byfetal stress, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  6.00 Month(s)
Gender  Both 
Details  All mother who will deliver at ≥34 week and physiologicaly stable babies.
Patients attendent who will and give informed and written consent
 
 
ExclusionCriteria 
Details  Babies delivered < 34 weeks of gestations.
Sick babies.
Babies with absolute contraindication for Breastfeeding.
Babies with congenital anomalies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
use LATCH score as an assessment and educational tool to promote breastfeeding  at birth, 1 week, 4 week, 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
to help mothers with Low LATCH scores, sustain exclusive breast feeding by councelling and education  at birth, 1 week, 4 week, 6 month 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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)   15/02/2025 
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 Yet Recruiting 
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  

All mother will be educated and motivated about proper breastfeeding technique, beforeintiation of first feed within 1 hour of life both in spontaneous vaginal delivery as well as inbabies delivered via caesarean section.

 

Feeding will be observed and checked for all five variables of LATCH score (table-1)  objectives and will be first recorded at 8 hours of life .Each variable will be given a maximum score of 2and The score will be recorded again at 48 hours.

 

A final LATCH score at 48 hours of more than 8, will be a positive predictor that the baby willbe breast feed for next 6 months. If the score in less than 8 at 48 hours, it will be taken as anindicator that the mother will be having difficulty in feeding the baby and will go for earlyweaning. Such mother will be intervened at that point of time and will be again educated aboutthe importance of breastfeeding.If any problems flat/ inverted nipple, sore / cracked nipple,fullness /engorgement of breast, block duct , mastitis or breast abscess, poor attachments arefound, they will be managed accordingly.

 

Before beginning the study nurses and pediatrics team will be trained in latch score evaluation and breastfeeding support. Mothers will be counselled and educated using pictures and videos over serval sessions  as well as practical instructions under the close supervision of the study’s researcher,The study team will offer support and counselling to mother in accordance with issues with breastfeeding that will be discovered during the initial assessment and educate mother on correct Breastfeeding technique and boost their confidence in Breastfeeding before discharge from hospital.

 

At 6 weeks mother will be contacted during routine immunization if they are coming forimmunization or by telephone and again will be contacted on telephone at 6 months to know ifbaby is on Exclusive Breast feeding or not .

 

If not, reason for early weaning will be enquired and noted at 6 weeks and 6 months respectively.

 
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