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临床试验/CTRI/2024/10/075801
CTRI/2024/10/075801
尚未招募
不适用

High (180 ml/kg) versus standard (150 to 160 ml/kg) volume feeding among preterm very low birth weight infants in a tertiary level SNCU - A randomized controlled trial.

Department of pediatrics Guru Gobind Singh medical college and hospital Faridkot1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年11月11日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Department of pediatrics Guru Gobind Singh medical college and hospital Faridkot
入组人数
104
试验地点
1
主要终点
To compare the growth velocity weight in gram per kg per day in very low birth weight neonates fed with standard versus high volume feeds.

概览

简要总结

Postnatal growth of very low birth weight neonates is a very important aspect of their management. Prevalence of postnatal growth restriction in preterm as well as low birth weight neonates is quite high at time of discharge and matter of concern. A metanalysis of studies comparing high versus standard volume enteral feeds in preterm and low birth weight infants conducted in 2021 concluded that high volume feeds, more than 180 ml per kg improve weight gain during hospital stay. The available data were inadequate to compare other anthropometric parameters or adverse outcomes in preterm very low birth weight fed with high volume versus standard volume enteral feeds. They concluded that further studies are needed on the subject. Therefore, we planned this randomized controlled trial to compare study high volume versus standard volume feeds in very low birth weight infants.

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
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Preterm neonates having birth weight less than or equal to 1500gm with postnatal age less than 14 days Both inborn and out-born neonates will be enrolled Baby should be hemodynamically stable and have achieved feeding volume of at least 100ml/kg/day.

排除标准

  • Hemodynamically significant patent duct arteriosus.
  • Any Necrotizing enterocolitis at admission.
  • Known Congenital neuro-malformations or gastrointestinal malformation Suspected Chromosomal anomalies.
  • Refusal of consent.

结局指标

主要结局

To compare the growth velocity weight in gram per kg per day in very low birth weight neonates fed with standard versus high volume feeds.

时间窗: weight will be measured daily and weekly weight gain will be measured

次要结局

  • To compare the other anthropometric measures viz length & head(circumference, & postnatal growth failure among these two groups.)

研究者

发起方
Department of pediatrics Guru Gobind Singh medical college and hospital Faridkot
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sunpreet Kaur

Guru Gobind Singh Medical college and hospital faridkot , Punjab

研究点 (1)

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