| CTRI Number |
CTRI/2025/07/092019 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to show the effect of weight gain in low birth weight newborns through a programmed breastfeeding counselling in mothers |
|
Scientific Title of Study
|
Efficacy of structured breast feeding counselling program on maternal breast feeding practice and weight gain pattern among low birth weight neonates - A randomised 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 |
Saranya v n |
| Designation |
Postgraduate, Department of paediatrics |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
No 4, department of paediatrics, Mahatma Gandhi Medical College and Research Institute, pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8508885838 |
| Fax |
|
| Email |
saranya.message@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. K. Karthikeyan |
| Designation |
Professor, Department of pediatrics |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
No 4, department of paediatrics, Mahatma Gandhi Medical College and Research Institute, pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India
No 4, department of paediatrics, Mahatma Gandhi Medical College and Research Institute, pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443882632 |
| Fax |
|
| Email |
drkk3179@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saranya v n |
| Designation |
Postgraduate, Department of paediatrics |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
No 4, department of paediatrics, Mahatma Gandhi Medical College and Research Institute, pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8508885838 |
| Fax |
|
| Email |
saranya.message@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi medical college and research institute, Pillaiyarkuppam, Pondicherry 607402, India. |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi medical college and research institute |
| Address |
Mahatma gandhi medical college and research institute, pillaiyarkuppam, pondicherry, PONDICHERRY, 607402
INDIA |
| Type of Sponsor |
Research institution |
|
|
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 Saranya VN |
Mahatma gandhi medical college and research institute |
No H1, postnatal ward, Department of Paediatrics,
Mahatma Gandhi medical college and research institute, Pillaiyarkuppam,
Pondicherry
PONDICHERRY
607402
INDIA
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
8508885838
0
Saranya.message@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z059||Observation and evaluation of newborn for unspecified suspected condition ruled out, (2) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Outcomes of weight gain in low birth weight neonates via structured breastfeeding counseling in breastfeeding mothers |
All eligible mothers who meet the inclusion criteria will be approached by the principal investigator, provided with a detailed participant information sheet, and enrolled after obtaining written informed consent. Following this, participants will be randomly assigned using computer-generated numbers to receive either routine counselling or structured breastfeeding counselling (SBC) within 72 hours of birth. The control group will receive routine care consisting of standard breastfeeding support offered by doctors and nurses in the newborn unit, including a brief 10-minute session on the importance of breastfeeding and feeding patterns for low birth weight (LBW) infants. Mothers in the intervention group will receive structured counselling from trained members of the institutional lactation support group, beginning with an educational video on feeding LBW neonates, followed by individual face-to-face counselling sessions lasting a minimum of 20 minutes. The first session will occur within 24 hours of delivery, with at least three and up to five sessions during the hospital stay, and one final session within 24 hours before discharge. Daily in-hospital visits will be conducted to address breastfeeding difficulties. The counselling will focus on exclusive breastfeeding for LBW infants, optimal feeding frequency and duration, skin-to-skin contact, common challenges in LBW care, and appropriate feeding practices. Weekly follow-up calls will be made post-discharge until the infant is six months old or until breastfeeding is discontinued. At the first counselling session, mothers will receive a booklet developed by the department, with a brief orientation provided on its contents. Infant weight will be measured daily during hospitalization using a standard digital scale, calibrated with a 500 g test weight and accurate to 10 g. Weight loss up to 10% of birth weight is expected in the first five days, with a subsequent daily gain of at least 10 g. After discharge, weight will be recorded weekly for two weeks, then monthly until three months of age. Any indication of inadequate weight gain will prompt medical intervention. The Breastfeeding Observation Form by BPNI, containing 17 items assessing key breastfeeding practices (such as infant positioning, latching, and maternal comfort), will be applied at birth, day three, before discharge, and at the one-month follow-up. The validity of this checklist will be confirmed through qualitative content validity, and reliability will be tested using intra-class correlation coefficients in a pilot study involving 20 mothers of LBW infants. All collected data will be coded, compiled, and entered into Excel, with statistical analysis performed using SPSS software. |
| Comparator Agent |
Post natal mothers of Low birth weight neonates under routine counselling |
All eligible mothers who meet the inclusion criteria and they will be randomly assigned using computer generated numbers to receive routine breastfeeding counselling.The
Weight of the neonates and breastfeeding practices will be checked at birth and at discharge and follow up weight via phone call at 3rd and 6th month of age. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal women more than 18 years of age
Intramural low birth weight neonates of those whose mothers completed the counseling sessions |
|
| ExclusionCriteria |
| Details |
• Postnatal women who are unable to speak and / or hear and who are seriously ill during data collection.
• Multiple births
• Neonates with suspected chromosomal abnormalities
• Newborns with serious congenital malformations
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Need for structured breastfeeding counseling in postnatal mothers.
2. Inspecting the efficacy of breastfeeding pattern through Breastfeeding observation form
3.Monitoring weight gain pattern in low-birth weight neonates.
|
At birth and during hospital stay, 1st, 2nd, 4th and 6months of age of neonate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Enhance the practices of Exclusive breastfeeding.
|
At discharge, 1st , 2nd, 4th, & 6 months of age |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="1"
Months="6"
Days="20" |
|
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
|
To evaluate the efficacy of structured breastfeeding counseling in postnatal mothers and the outcome of weight gain patterns in their low birth weight neonates.
Purpose of Trial -
1. To design a
structured breastfeeding counseling program incorporating multimedia tools (
Flipcharts, videos, social media and
video counselling).
2. To study the Efficacy of
Structured breastfeeding counselling among the
study subjects in terms of
Feeding
outcomes as assessed by the Breastfeeding Observation form
Weight
gain pattern of neonates till discharge
Adherence
to Exclusive breastfeeding at 3months and 6 months
Incidence
of
breastfeeding-related problems post-discharge
Weight
gain pattern among the infants at 1month, 2months, 4 months and 6 months of
life |