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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  
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 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  
Status 
Not Applicable 
 
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.

 
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