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Clinical Trials/CTRI/2025/07/092019
CTRI/2025/07/092019Not yet recruitingPhase 3 4

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

Mahatma Gandhi medical college and research institute1 site in 1 country66 target enrollmentStarted: August 10, 2025Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Enrollment
66
Locations
1
Primary Endpoint
1.Need for structured breastfeeding counseling in postnatal mothers.

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Postnatal women more than 18 years of age Intramural low birth weight neonates of those whose mothers completed the counseling sessions.

Exclusion Criteria

  • • 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.

Outcomes

Primary Outcomes

1.Need for structured breastfeeding counseling in postnatal mothers.

Time Frame: At birth and during hospital stay, 1st, 2nd, 4th and 6months of age of neonate

2. Inspecting the efficacy of breastfeeding pattern through Breastfeeding observation form

Time Frame: At birth and during hospital stay, 1st, 2nd, 4th and 6months of age of neonate

3.Monitoring weight gain pattern in low-birth weight neonates.

Time Frame: At birth and during hospital stay, 1st, 2nd, 4th and 6months of age of neonate

Secondary Outcomes

  • Enhance the practices of Exclusive breastfeeding.

Investigators

Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Saranya v n

Mahatma Gandhi Medical College and Research Institute

Study Sites (1)

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