| CTRI Number |
CTRI/2025/11/097598 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Breastfeeding Difficulties at 6 to 12 hours of life and at discharge using the scores to assess breast feeding in babies |
|
Scientific Title of Study
|
Assessment of Breastfeeding Difficulties at 6-12 hours of delivery and at discharge using the LATCH SCORE: A Prospective Observational 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 |
Abhilasha Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
ESIC model Hospital and PGIMSR, Basaidarapur |
| Address |
Postnatal ward, second floor, C block room no 201-204, Paediatrics Department, ESIC Hospital Basaidarapur
New Delhi
DELHI
110092
India |
| Phone |
9773572301 |
| Fax |
|
| Email |
sabhilasha96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumari Pratima |
| Designation |
Associate Professor |
| Affiliation |
ESIC model Hospital and PGIMSR, Basaidarapur |
| Address |
Room no 104, near doctors duty room, C block Old building, Paediatrics Department, first floor, Esic Hospital Basaidarapur
New Delhi
DELHI
110015
India |
| Phone |
7042443562 |
| Fax |
|
| Email |
drkpratima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumari Pratima |
| Designation |
Associate Professor |
| Affiliation |
ESIC model Hospital and PGIMSR, Basaidarapur |
| Address |
Room no 104, near doctors duty room, first floor, C-block Old building, Paediatrics Department, Esic Hospital Basaidarapur
New Delhi
DELHI
110015
India |
| Phone |
7042443562 |
| Fax |
|
| Email |
drkpratima@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC model hospital and PGIMSR,Basaidarapur |
|
|
Primary Sponsor
|
| Name |
Abhilasha Singh |
| Address |
C-701, Sukhsagar, Apartment,I.P Extension, Patparganj, Delhi, India, 110092 |
| 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 |
| DrAbhilasha Singh |
ESIC MODEL HOSPITAL AND PGIMSR, BASAIDARAPUR, NEW DELHI |
Postnatal ward second floor, room no 201-204, C-block old building, Paediatrics Department, Esic Hospital, Basaidarapur
West
DELHI |
9773572301
sabhilasha96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, ESI-PGIMSR, Basaidarapur, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P925||Neonatal difficulty in feeding atbreast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
9.25 Month(s) |
| Age To |
10.50 Month(s) |
| Gender |
Both |
| Details |
All postnatal mothers having neonates from the gestation 37 weeks and above
Singleton live births |
|
| ExclusionCriteria |
| Details |
Mothers with severe postpartum complications
Newborns admitted to NICU
Newborns with congenital anomalies affecting breastfeeding like cleft lip,cleft palate
Mothers with contraindications for breastfeeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of mother-infant dyads having low LATCH score at 6-12 hours of birth and at discharge |
Percentage of mother-infant dyads having low LATCH score at 6-12 hours of birth and at discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between LATCH score at discharge with exclusive breastfeeding rate & weight at 6 weeks of age |
weight assessment at 6 weeks of life |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
30/11/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sabhilasha96@gmail.com].
- For how long will this data be available start date provided 30-12-2027 and end date provided 30-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Informed consent will be taken from the enrolled mother-infant dyads meeting the inclusion criteria. Demographic details of the recruited mothers will be recorded.The study is designed as a prospective observational study which will be conducted in the postnatal ward of ESIC, Hospital and PGIMSR, Basaidarapur. A total of 180 mothers will be enrolled in the study. Data collection will be done using a pre-designed proforma. Initial data will be collected within the first 6-12 hrs of observing a breastfeeding session using the LATCH Score. Breastfeeding counselling will be done daily till discharge. Again the LATCH Score will be calculated at the time of discharge. The participants will be followed up at 6 weeks of age through an in-person visit at the well-baby clinic. Breast feeding status will be assessed and weight of the baby will be recored. The LATCH Score comprises of five components. The five components are as follows, LATCH, AUDIBLE SWALLOWING, TYPE OF NIPPLE, COMFORT During breastfeeding and HOLD. A LATCH Score between 8-10 is considered good, 4-7 is considered moderate and less than 4 is considered poor. The data will be entered into the MS Excel spreadsheet and analysis will be done using the software SPSS Version 25. Categorical variables will be presented in frequency and percentage and continuous variables will be presented as mean plus/minus Standard Deviation and median. The quantitative variables will be compared using t-test and Mann Whitney U test. Qualitative variables will be compared by chi-square testing. For testing significance P-value of less than 0.05 will be considered statistically significant. |