| 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
|
|
|
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
|
|
|
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
|
|
|
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. |