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CTRI Number  CTRI/2026/02/104329 [Registered on: 19/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the intervention of giving mother’s own milk in the mouth of premature babies, with the main outcome being the time taken to reach full milk feeding. 
Scientific Title of Study   Efficacy of Oropharyngeal Administration of Mother’s Own Milk on Time to Achieve Full Enteral Feeds in Preterm Neonates: A Randomized Control Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Pujara 
Designation  Associate Professor  
Affiliation  Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University 
Address  Department of Neonatology Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University, Karamsad

Anand
GUJARAT
388325
India 
Phone  9426575197  
Fax    
Email  drreshmapujara@yahoo.co.uk  
 
Details of Contact Person
Scientific Query  
Name  Dr Monil Sarode 
Designation  Senior Resident 
Affiliation  Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University 
Address  Department of Neonatology Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University, Karamsad

Anand
GUJARAT
388325
India 
Phone  9137658610  
Fax    
Email  monilsarode78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reshma Pujara 
Designation  Associate Professor  
Affiliation  Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University 
Address  Department of Neonatology Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University, Karamsad

Anand
GUJARAT
388325
India 
Phone  9426575197  
Fax    
Email  drreshmapujara@yahoo.co.uk  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Reshma Kushal Pujara 
Address  Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University, Karamsad, Anand, Gujarat - 388325 
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 Reshma Pujara  Shree Krishna hospital  Room NO 253, Inborn NICU, Department of Neonatology Shree Krishna Hospital PSMC, Karamsad.
Anand
GUJARAT 		 9426575197

drreshmapujara@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Committee-2 Bhaikaka University, Karamsad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Receive standard NICU care; no oropharyngeal administration of Mother’s Own Milk prior to enteral feeding as per standard feeding guidelines 
Intervention  Oropharyngeal Administration of Mothers own milk in preterm neonates  Milk source: Expressed mother’s own milk. Volume per administration: 0.2 mL to buccal mucosa and oropharynx. Frequency: To be initiated within 72 hours of birth, 3 hourly till the new born reaches full enteral feeds. Duration: Continue until the baby achieves full enteral feeds (150 mL/kg/day for 24 h). Method: Use a sterile 1 mL syringe (no needle). Place baby in supine position, gently insert the syringe in the buccal cavity and slowly instill 0.1ml of mother’s own milk over 10–20 seconds. Observe baby for 2–3 minutes for any regurgitation, desaturation or bradycardia. Timing of initiation: Initiate as early as possible preferably within 72 hours of birth. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Day(s)
Gender  Both 
Details  Preterm neonates (less than or equal to 32 weeks of gestation) born at Shree Krishna hospital and admitted to the NICU. 
 
ExclusionCriteria 
Details  Major congenital malformations
Severe perinatal asphyxia
Maternal contraindication for breastfeeding 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine whether early oropharyngeal administration of mother’s own milk (MOM) reduces the time taken to achieve full enteral feeds in preterm neonates (less than or equal to 32 weeks of gestation), as compared to standard care.  Days from birth to tolerance of 150 mL/kg/day of enteral feeds for 24 hours without significant intolerance 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of feeding intolerance between the intervention and control group  Every 24 Hours 
To determine the number of newborns having Late-onset sepsis (LOS) in each group  after 72 hours of life at every 24 Hours 
To determine the number of newborns being on mother’s own milk (MOM) when reached full enteral feeds in each group  When reaches full enteral feeds 
To Determine the number of newborns being discharged on exclusive breastfeeding amongst both the groups.  At discharge  
To compare overall length of hospital stay (in days) between the groups.  At discharge 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   16/03/2026 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drreshmapujara@yahoo.co.uk].

  6. For how long will this data be available start date provided 16-11-2027 and end date provided 16-03-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Very preterm and VLBW neonates frequently experience delayed enteral feeding due to gastrointestinal immaturity clinical instability and intolerance to early feeding resulting in prolonged parenteral nutrition central line use risk of sepsis and extended hospital stay Although oropharyngeal administration of mothers own milk MOM has been proposed as a simple non invasive strategy to promote early feeding readiness and immune protection its routine use has not yet been standardized in most Indian NICUs due to limited local evidence Therefore there is a need to evaluate the effectiveness and feasibility of this intervention in our setting 
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