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临床试验/CTRI/2025/07/092019
CTRI/2025/07/092019尚未招募Phase 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 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
66
试验地点
1
主要终点
1.Need for structured breastfeeding counseling in postnatal mothers.

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

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

排除标准

  • • 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.

结局指标

主要结局

1.Need for structured breastfeeding counseling in postnatal mothers.

时间窗: 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

时间窗: 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.

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

次要结局

  • Enhance the practices of Exclusive breastfeeding.

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Saranya v n

Mahatma Gandhi Medical College and Research Institute

研究点 (1)

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