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临床试验/CTRI/2023/09/057574
CTRI/2023/09/057574尚未招募4 期

Effectiveness of interventional program on establishing mothers own milk feeding in preterm neonates - A prospective interventional study

Not applicable1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2023年9月17日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
344
试验地点
1
主要终点
Mothers own milk feeding rates in 34 weeks babies at corrected gestational age of 40 weeks

研究概览

简要总结

Background:

Breastfeeding is the optimal nutrition for both term and the preterm neonate. But various factors affect the milk production in mothers. Preterm birth itself acts as a stressor and impacts the breastfeeding in preterm mothers. Breastfeeding has a range of health benefits to the breastfeeding dyad. Apart from being economical, it helps reduce the risk of otitis media, respiratory tract infections, asthma and atopy, gastroenteritis and so on. In addition to these benefits, breastfeeding offers improved neuro-developmental outcomes to the premature baby.With increasing preterm births and their related complications, it becomes paramount importance to take measures that affect their morbidity and mortality. Globally, an estimated 13.4 million babies were born preterm in 2020 with preterm complications causing death in approximately 9,00,000 deaths in 2019. This group of infants are born with varying needs including nutrient needs based on their prematurity. Prematurity affects the accretion that happens in the late trimester, making them prone to lack of vital support for their growth and development. Hence, the emphasis on the breastfeeding and usage of mother’s own milk to meet all the needs of the premature baby in a holistic way. But the problem arises due to delayed stage II of lactogenesis, which occurs increasingly in these preterm mothers due to the premature nature of delivery. Hence it becomes important to intervene in this situation, as this delayed lactogenesis may benefit from professional education, interventions and support. Often eligible babies for enteral feedings are kept nil per oral because of non-availability of expressed breast milk and even when established, it becomes a difficult task to successfully discharge a preterm neonate on exclusive mother’s own milk feeding. Hence this study is being undertaken to form a structured intervention protocol to help increase the rates of mother’s own milk feeding in preterm neonates in our institution.

AIM

To evaluate interventions in NICU to increase the exclusive mother’s own milk feeding rates in preterm babies by 20%

OBJECTIVES

Primary:

To study the effectiveness of interventional program on the proportion of babies receiving exclusive feeds by Mother’s own milk at a corrected gestational age of 40 weeks.

Secondary:

1.     To measure the proportion of babies receiving expressed breast milk on 1st, 7th and 14th day after a structured interventional program

2.     To measure the rate of growth, by weight gain in both the groups.

3.     To measure the rate of necrotizing enterocolitis and sepsis in babies on exclusive mother’s own milk feeding.

4.     To measure the time to reach full enteral feeding

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • Hemodynamically stable preterm neonates less than 34 weeks of gestation.

排除标准

  • Major congenital anomalies.

结局指标

主要结局

Mothers own milk feeding rates in 34 weeks babies at corrected gestational age of 40 weeks

时间窗: Corrected gestational age of 40 weeks for each baby

次要结局

  • Proportion of babies receiving expressed breast milk on 1st, 7th & 14th day after a structured interventional program

研究者

申办方类型
Other [na]

研究点 (1)

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