| CTRI Number |
CTRI/2025/08/092356 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Improving Early Breastfeeding in Newborns Through Structured Hospital Interventions: A Study at a Tertiary Care Hospital |
|
Scientific Title of Study
|
Effect of structured quality improvement interventions on early initiation of breastfeeding among newborns at a tertiary health care hospital: A Quasi-experimental Study |
| Trial Acronym |
EARLY-QI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepanshu Sharma |
| Designation |
Post Graduate DNB Paediatrics |
| Affiliation |
Maharaja Agrasen Medical College Agroha |
| Address |
91, Pediatrics OPD, MAMC, Agroha 91, Pediatrics OPD, MAMC, Agroha Hisar HARYANA 125047 India |
| Phone |
9416128382 |
| Fax |
|
| Email |
sharma.94161@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suman Rana |
| Designation |
Assistant Professor |
| Affiliation |
Maharaja Agrasen Medical College Agroha |
| Address |
Room 91, Pediatrics OPD,Department of pediatrics MAMC, Agroha
Hisar HARYANA 125047 India |
| Phone |
9992156776 |
| Fax |
|
| Email |
suman_13doc@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Surendra Kumar |
| Designation |
Associate Professor |
| Affiliation |
Maharaja Agrasen Medical College Agroha |
| Address |
Room no-91, Pediatrics OPD,Department of pediatrics MAMC, Agroha Pediatrics OPD, MAMC, Agroha Hisar HARYANA 125047 India |
| Phone |
7014197954 |
| Fax |
|
| Email |
drsgodara2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Medical College Agroha(125047), Hisar, HARYANA, INDIA |
|
|
Primary Sponsor
|
| Name |
Maharaja Agarsen Medical College |
| Address |
Agorha(125047), Hisar, Haryana, INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 Deepanshu Sharma |
Maharaja Agrasen Medical College, Agroha |
Room 91, Department of Pediatrics OPD, MAMC agroha, Hisar, Haryana 125047 Hisar HARYANA |
9416128382
sharma.94161@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe For Human Research Maharaja Agarsen Medical college , Agroha , Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthcare professionals involved in immediate newborn care and breastfeeding initiation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sensitization of Healthcare workers (doctors, nurses, midwives) from Pediatrics and Obstetrics departments involved in immediate newborn care and breastfeeding initiation |
Seminar on importance of early initiation of Breastfeeding in interdepartmental meetings, through social media, reminders and Appointing Incharge for monitoring for next 2 months |
| Comparator Agent |
Standard care before the intervention applied |
Standard hospital practices for initiation of breastfeeding as followed before implementation of QI intervention, without structured training, reminders, or checklists. Pre-intervention baseline data will be collected for 2 months |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
All live-inborn neonates whose parents give consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
Neonates with any congenital anomalies affecting feeding (e.g., cleft lip/palate, tracheoesophageal fistula).
New-born requiring NICU (Neonatal Intensive Care Unit) admission or intensive monitoring post-delivery.
When breast feeding is not indicated (e.g., Galactosemia, active herpes infection).
Severe obstetric complications leading to ICU admission of mother (e.g., postpartum hemorrhage needing surgery or ventilation).
Deliveries conducted outside the hospital (out-born).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of newborns recieving Early initiation of Breastfeeding (Within First hour of life) |
First hour after Birth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="85" Sample Size from India="85"
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)
|
21/08/2025 |
| 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="0" Months="6" 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
|
The proposed study titled “Effect of Structured Quality Improvement Interventions on Early
Initiation of Breastfeeding Among Newborns at a Tertiary Health Care Hospital:
A Quasi-experimental Study” aims to enhance the rate of
breastfeeding initiation within one hour of birth (EIBF), a WHO-recommended
practice proven to reduce neonatal morbidity and mortality. Despite known
benefits, EIBF rates remain low, particularly in tertiary settings. This study
will be conducted in the Departments of Pediatrics and Obstetrics &
Gynaecology at Maharaja Agrasen Medical College, Agroha, and will use the Plan-Do-Study-Act (PDSA) cycle
framework to implement structured quality improvement (QI) interventions.
Healthcare providers—doctors, residents, and nurses—will be sensitized through
educational sessions, posters, checklists, and digital reminders. The
intervention will be conducted in two phases, assessing baseline data followed
by implementation and post-intervention analysis to track improvements.
Exclusions include neonates with congenital feeding issues, NICU admissions, or
severe maternal complications. Sample size will include all eligible 85
newborns during the study window, estimated using OpenEpi. The primary outcome
will be the improvement in EIBF rates, and secondary outcomes include identifying
barriers like staff training gaps, interdepartmental miscommunication, and
post-operative delays. Data will be collected in structured proformas and
analyzed using standard statistical tools. Ethical clearance will be obtained,
and written informed consent will be taken. This study aims to offer a
scalable, sustainable model for enhancing early breastfeeding, with the
potential to impact neonatal care policies and protocols in similar healthcare
settings across low- and middle-income countries. |