CTRI

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CTRI Number

CTRI/2024/07/071488 [Registered on: 29/07/2024] Trial Registered Prospectively

Last Modified On:

26/07/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Process of Care Changes
Behavioral
Other (Specify) [Antenatal Counselling]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect of teaching breastfeeding methods during pregnancy on breastfeeding duration after birth

Scientific Title of Study

Effect of Antenatal Lactation Counselling on Exclusive Breastfeeding in Primigravida Mothers in a Tertiary Care Setup An Open labelled Randomized Control Trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Bhabesh Kant Chowdhary
Designation	Associate Professor Neonatology
Affiliation	All India Institute of Medical Sciences Patna
Address	Department of Neonatology, BGA OT Complex, Ground Floor, IPD Building, All India Institute of Medical Sciences, Patna, Bihar, India Patna BIHAR 801507 India
Phone
Fax
Email	drbhabeshkc@aiimspatna.org

Details of Contact Person
Scientific Query

Name	Richie Dalai
Designation	Assistant Professor Neonatology
Affiliation	All India Institute of Medical Sciences Patna
Address	Department of Neonatology, BGA OT Complex, Ground Floor, IPD Building All India Institute of Medical Sciences Patna, Phulwari Sharif, Patna Patna BIHAR 801507 India
Phone	09914842233
Fax
Email	richie.aiims@gmail.com

Details of Contact Person
Public Query

Name	Richie Dalai
Designation	Assistant Professor Neonatology
Affiliation	All India Institute of Medical Sciences Patna
Address	Department of Neonatology, BGA OT Complex, Ground Floor, IPD Building, All India Institute of Medical Sciences Patna, Phulwari Sharif, Patna Patna BIHAR 801507 India
Phone	09914842233
Fax
Email	richie.aiims@gmail.com

Source of Monetary or Material Support

All India Institute of Medical Sciences Patna, Patna, Bihar, Pin Code: 801507 India

Primary Sponsor

Name	Not Applicable
Address	No sponser
Type of Sponsor	Other [No Sponser]

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 Bhabesh Kant Chowdhary	All India Institute of Medical Sciences Patna	Department Of Neonatology, BGA OT Complex, Ground Floor, IPD Building, All India Institute of Medical Sciences Patna, Phulwari Sharif, Patna Patna BIHAR	7871592369 drbhabeshkc@aiimspatna.org

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIMSPATNA	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Pregnant Individuals

Intervention / Comparator Agent

Type	Name	Details
Intervention	Antenatal counselling Arm	A total of 100 primigravida mothers who are visiting antenatal clinic for regular antenatal checkup.These women will be given of lactation counselling during their each antenatal visit in OPD. Each session will be of 30 minutes each. For each participant in group A , minimum two sessions of counselling will be done.
Comparator Agent	Only Postnatal counselling Arm	A total of 100 primigravida women who are visiting antenatal clinic for regular checkup They will receive regular lactation counselling in post natal ward after delivery.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	A total of 200 women who are coming for regular antenatal visits to AIIMS PATNA will be included in our study.

ExclusionCriteria

Details

-Mothers with Cancer breast or on cytotoxic and chemotherapy drugs.
-Mothers of babies born with oro-pharyngeal abnormalities like cleft lip and palate
-Mother of babies requiring NICU admission within 24 hours of birth
-Mothers admitted in ICU within 24 hours of delivery

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
The initiation time point of breastfeeding and total duration of exclusive breastfeeding.	Day 1 and Day 7,6 week ,10 week,14 week and 6 months

Secondary Outcome

Outcome	TimePoints
-Use of prelacteal feeds at birth -Use of pacifiers/ teats -Use of formula/animal milk -Reason for starting formula feed or animal milk : -If the child has suffered from any illness/ hospitalizations	Day 1, Day 7,6 week ,10 week,14 week and 6 months

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)

07/08/2024

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 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

EFFECT OF ANTENATAL LACTATION COUNSELLING ON

EXCLUSIVE BREASTFEEDING IN PRIMIGRAVIDA MOTHERS IN A

TERITARY CARE SETUP :OPEN LABELLED RANDOMIZED

CONTROL TRIAL

Introduction:

Breast milk is the ideal source of nutrition for babies less than 6 months of age. As per WHO

guidelines exclusive breastfeeding should be done till 6months of age and breastfeeding

should be continued in weaning children till 2 years of age. Breast milk has optimum amount

of nutrition (carbohydrate, fat and protein) required for the growth of the infant. Breast milk

is rich in antibodies which helps to protect infants against childhood illnesses. Breast milk

also helps in quick recovery from diseases. Exclusive breastfeeding has the potential to

reduce under 5 mortality rate by 13%. Long term benefits of breastfeeding have also been

established, a systematic review conducted by WHO suggested that breastfeeding helped in

improving IQ and longer duration of breastfeeding played protective role against type 2 DM

and obesity. The promotion and support of breastfeeding is a global priority and important

child survival intervention. Antenatal counselling and postnatal support will help in early

initiation and exclusive breastfeeding and will improve rates of exclusive breastfeeding till 6

months of age.

Aims and Objectives:

Primary:

To assess the impact of antenatal lactation counselling in increasing the initiation and

duration of exclusive breastfeeding.

Secondary :

To compare the rates of illness and hospitalizations in infants who are exclusively breastfed

till 6 months of age versus those who are not exclusively breastfed.

Methodology: With the help of open labelled randomization participants will be divided in two groups. It will be conducted by Department of Pediatrics and Neonatology at AIIMS Patna. This is a single center study. A total of 200 women who are coming for regular antenatal visits will be included in our study. Based on open labelled randomization using sealed envelope software they will be divided in two groups. Written informed consent will be taken from all participants. Group A: A total of 100 primigravida mothers who are visiting antenatal clinic for

regular antenatal checkup.These women will be given of lactation counselling during their each antenatal visit in Pediatric OPD. Each session will be of 30 minutes each. For each participant in group A , minimum two sessions of counselling will be done. Group B: A total of 100 primigravida women who are visiting antenatal clinic for regular checkup They will receive regular lactation counselling in post natal ward after delivery. Post delivery, all the women will be followed up at our post natal ward, and the following points will be checked:

a) Initiation if breastfeeding within first 30-60 minutes after birth?

b) Frequency of breastfeeding

c) Use of prelacteal feeds

d) Use of pacifiers/ teats

e) Use of formula/animal milk

Both the groups will be followed up at Day 7,6 week ,10 week,14 week and 6 months

at AIIMS PATNA OPD or telephonically and following questions will be asked:

a) If exclusive breast feeding is being continued :

b) Use of formula feed or animal milk :

c) Reason for starting formula feed or animal milk :

d) If the child has suffered from any illness/ hospitalizations :

Implications:

With the help of this study we will be able to understand the barriers mothers face during

breastfeeding and how antenatal lactation counselling will help in promoting breastfeeding.