CTRI

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CTRI Number

CTRI/2025/07/091053 [Registered on: 16/07/2025] Trial Registered Prospectively

Last Modified On:

15/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Using mothers first milk in the babys mouth to help prevent infections in sick newborns admitted to NICU: A research study"

Scientific Title of Study

Application of buccal mucosal colostrum for first 48 hours of life to nenonates admitted in neonatal intensive care unit to prevent late onset neonatal sepsis within 14 days of life in a tertiary care hospital: A rondomised controlled trial

Trial Acronym

BUCCAL

Secondary IDs if Any

Secondary ID	Identifier
Nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Varnika Aggarwal
Designation	PG Resident
Affiliation	MAMC, Agroha
Address	Room 91, Department of pediatrics, A-Block Maharaja Agrasen Medical College, Agroha, Hisar, Haryana Hisar HARYANA 125047 India
Phone	08826649683
Fax
Email	aggarwalvarnika01@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Karnika Agrawal
Designation	Professor
Affiliation	Maharaja agrasen medical college,
Address	Room 91, Department of Paediatrics, A block, MAMC Agroha, Hisar Agroha Hisar HARYANA 125047 India
Phone	8059784475
Fax
Email	karnika.pediatrics@gmail.com

Details of Contact Person
Public Query

Name	Dr Karnika Agrawal
Designation	Professor
Affiliation	Maharaja Agrasen Medical College
Address	Room 91, Department of paediatrics, A block, MAMC Agroha, Hisar Agroha Hisar HARYANA 125047 India
Phone	8059784475
Fax
Email	karnika.pediatrics@gmail.com

Source of Monetary or Material Support

Nil

Primary Sponsor

Name	Maharaja Agrasen Medical College
Address	VPO-Agroha, NH-9, Hisar, Haryana 125047
Type of Sponsor	Other [Semi-government 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 Varnika Aggrawal	Maharaja Agrasen Medical College Agroha	Room no 91, department of Pediatrics, A BLOCK, MAMC Agroha, Hisar, Haryana 125047 Hisar HARYANA	08826649683 aggarwalvarnika01@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IEC FOR HUMAN RESEARCH, MAMC, AGROHA	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: P369\|\|Bacterial sepsis of newborn, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Buccal Mucosal Colostrum Administration	Neonates in this group will receive small amounts (approximately 0.2–0.5 ml) of freshly expressed maternal colostrum applied gently to the buccal mucosa every 3 hours using a sterile syringe or dropper. The intervention will begin within 6 hours of birth and continue for the first 48 hours.
Comparator Agent	Standard NICU Care	Neonates in this group will receive standard NICU management as per institutional protocol. No colostrum or placebo will be administered to the buccal mucosa.

Inclusion Criteria

Age From	1.00 Day(s)
Age To	28.00 Day(s)
Gender	Both
Details	All neonates admitted to NICU within 6 hours of life

ExclusionCriteria

Details

1 Neonates with major congenital anomalies requiring immediate surgical intervention
2 Neonates with early onset sepsis
3 Neonates where colostrum from mother is not available within first 6 hours
4 Neonates born from HIV positive mother
5 Neonates in whom feeding can be initiated within 48 hours of life
6 Neonates whose mother refuse to give consent

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Incidence of late onset sepsis(defined as sepsis occuring after 72 hours of life)	Incidence of late onset sepsis(defined as sepsis occuring after 72 hours of life) within 1 week, 10 days and 14 days of life

Secondary Outcome

Outcome	TimePoints
A. Incidence of NEC within 2 weeks B. Duration of hospital stay in days C. Mortality rate within 2 weeks	2 weeks

Target Sample Size

Total Sample Size="200"
Sample Size from India="200"
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)

30/07/2025

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

This randomized controlled trial aims to evaluate the effectiveness of buccal mucosal colostrum administration in preventing late-onset neonatal sepsis (LOS) among neonates admitted to the NICU within the first 6 hours of life. It will be conducted at Maharaja Agrasen Medical College, Agroha, the study will include 200 neonates randomly assigned into two groups: an intervention group receiving colostrum applied to the buccal mucosa every 3 hours for the first 48 hours, and a control group receiving standard NICU care without colostrum application. The primary objective is to compare the incidence of LOS (sepsis occurring after 72 hours of life) within the first 14 days. Secondary outcomes include the incidence of necrotizing enterocolitis (NEC), duration of hospital stay, and mortality. The study will use double-blinding and block randomization to ensure unbiased results. Exclusion criteria include neonates with major congenital anomalies, early-onset sepsis, unavailability of maternal colostrum, HIV-positive mothers, and neonates able to be fed orally within 48 hours. Data will be statistically analyzed using OpenEpi software, with a p-value <0.05 considered significant. Ethical approval has been obtained, and written informed consent will be taken from all participants’ Parents.