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临床试验/CTRI/2021/09/036791
CTRI/2021/09/036791招募中不适用

Newer intervention strategy for successful relactation of newborns and infants in private practice

Dr Selvan Rathinasamy1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年9月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Increase in the milk supply,adequete weight gain and successful relactation

研究概览

简要总结

To study the effectiveness of the newer intervention  strategy using breastfeeding educational videos (Produced by the global health media Ltd and IIT mumbai)  and find out their effectiveness in improving the breastfeeding success rate ,adequate milk transfer and successful relactation of newborns and infants. This prospective observational study will done at the Pediatric clinic after obtaining informed consent. The details will be collected through breastfeeding questionnaire and B-R-E-A-S-T feeding observation form and interviews. Additional details on family support, reasons for stopping breastfeeding  relactation and job pressures  will be collected. Mother and baby dyad fulfilling the inclusion criteria will be entered in the study . Breastfeeding educational videos by Global health media limited and IIT mumbai (in Tamil) will be shown and correct technique will be taught. A personal copy will be shared with the parents. Skilled trained staffs under the supervision of principal investigator will be assessing and counselling them. The primary outcome will be initiation of relactation, increase in milk supply . The secondary outcome will be the educational video’s contribution in reducing relactation failure rate and improving the success rate. Mother and infant dyads will be followed up at 7th, 14 th, 45 th, 105 and 180 days of baby’s life during follow up and vaccination visits. If visits are not possible telephonic follow up  focusing on the status of relactation enquired . Positive emotional and psychological support will be provided .SPSS statistical software version 25 will be used to analyze the data. Logistic regression will be calculated to assess the odds ratio promoting success and p value of less than 0.05 will be considered significant

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 1.The newborn or infant and mother dyad who have low milk supply 2.The newborns or infant and mother dyad who have partial or total lactation failure 3.The newborns or infant and mother dyad who are willing for relactation or advised relactation.

排除标准

  • Mothers with systemic illness and on medications which are contraindicated in lactation 2.Babies who had severe birth problems, congenital, genetic and chromosomal anomalies.

结局指标

主要结局

Increase in the milk supply,adequete weight gain and successful relactation

时间窗: Day 7 | day 14 | day 45 | day 105 | day 180

次要结局

  • Educational videos contribution in helping mothers breastfeeding and reducing relactation failure rate(Day 7)

研究者

发起方
Dr Selvan Rathinasamy
申办方类型
Other [Private Practitioner]

研究点 (1)

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