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临床试验/CTRI/2023/11/059967
CTRI/2023/11/059967尚未招募不适用

Simulation-based versus video-based training of primiparous mothers for effective breastfeeding: A Randomized Controlled Trial

Dr Jyoti1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2023年11月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
350
试验地点
1
主要终点
Pre and post-training LATCH score

研究概览

简要总结

Breast milk is the natural and ideal food for healthy growth and development of newborn. Exclusive breast feeding for 6 months of life is the optimal way of feeding infants.Considering the importance of breastfeeding, we designed this study to improve breastfeeding by training mothers and to find out the better method of breastfeeding training out of two methods i.e. video based or simulation based training. We have chosen the LATCH scoring system for this study which is a simple breastfeeding assessment tool that has been used to assess breastfeeding practices. A trained person will be assigned to do LATCH scoring in these mothers within 24 hours of delivery. After pre-training LATCH scoring, the mothers will be randomly allocated to one of the two training groups by an online generated random number table. Group A will be trained in breastfeeding through Lactation Simulation Model while group B will be trained using standardized video. Allocation concealment will be done by Sequentially numbered opaque sealed envelopes (SNOSE) method. Again, LATCH scoring will be done at 48 hours of delivery by the same person who assessed LATCH scoring earlier. LATCH score improvement in both groups will be compared and data will be assessed for the result by a data analyst who will be blinded for the type of groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Primiparous mothers whose babies are term (37 0/7 to 41 6/7 weeks) and physiologically stable.

排除标准

  • Primiparous mothers whose babies are preterm (<37 weeks)
  • Primiparous mothers whose babies are admitted in Neonatal Intensive Care Unit (NICU)
  • Primiparous mothers admitted in Intensive Care Unit (ICU)
  • Mothers who refused to give consent.

结局指标

主要结局

Pre and post-training LATCH score

时间窗: Two Days

次要结局

未报告次要终点

研究者

发起方
Dr Jyoti
申办方类型
Other [self]

研究点 (1)

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