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临床试验/CTRI/2017/09/009813
CTRI/2017/09/009813已完成不适用

Postnatal growth evaluation in preterm babies on expressed breast milk feeding admitted in NICU

Vishal Vishnu Tewari1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年10月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Mean weight gain (in gm per kg per day), mean increase in Occipito-frontal circumference (in cm per week) and mean increase in length (in cm per week)

研究概览

简要总结

This study is an observational analytical study with 3 cohorts of preterm neonates below 33 weeks of period of gestation who required neonatal intensive care unit (NICU) admission. The neonates in these three cohorts were provided expressed breast milk feeding in the following manner:-

a.       expressed breast milk going upto 200 ml/kg/day supplemented with Hind-milk

b.      expressed breast milk upto 150-160 ml/kg/day supplemented with liquid calcium phosphate  and liquid multivitamin-micronutrient

c.       expressed breast milk upto 150-160 ml/kg/day supplemented with multicomponent human milk fortifier powder

The goal of preterm nutrition is optimal postnatal growth and expressed breast milk feeding is unarguably the preferred form of milk. However it may not be able to provide the preterm with adequate protein, calcium, sodium, fats and other nutrients. Increasing total enteral intake, addition of hind-milk, fortification with human milk fortifier or supplementation by adding liquid calcium phosphate and multivitamin-micronutrient liquid are different strategies which are adopted with merits and demerits of each. The addition of multicomponent human milk fortifier powder has been shown to increase the risk of late onset sepsis and necrotizing enterocolitis in preterm neonates, while addition of liquid suspension of calcium phosphate results in milk fat chelation and reduced availability of milk fats and fat soluble vitamins and increased risk of feed intolerance. Enteral feeding upto 200 ml per kg per day is tolerated by preterm neonates and may produce optimal growth. Fortifying with hind-milk increases the availability of fats. This reduces the risk of late onset sepsis, NEC and feed intolerance and allows optimal postnatal growth.

This study is aimed as ascertaining the most suitable manner of enteral feeding in preterm neonates by using the primary outcome measure of mean weight gain (in gm per kg per day), mean increase in OFC (in cm per week) and mean increase in length (in cm per week). The secondary outcomes which would be studied are time to achieve and sustain full feeding for at least 5 successive days, time to regain birth weight, episodes of feed intolerance requiring interruption of feeds, necrotizing enterocolitis – all stages, late onset sepsis – probable and blood culture positive, duration of oxygen therapy and all-cause mortality.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 7.00 Day(s)(—)
性别
All

入选标准

  • Intramural preterm neonates below 33 weeks period of gestation requiring admission to the neonatal intensive care unit.

排除标准

  • Preterm neonate below 27 weeks period of gestation
  • Preterm neonate more than equal to 33 weeks period of gestation
  • Preterm intrauterine growth restricted neonate with antenatal Doppler abnormalities
  • Preterm neonate with a life threatening congenital malformation or intestinal anomaly
  • Preterm neonate with dysmorphism
  • Extramural neonate.

结局指标

主要结局

Mean weight gain (in gm per kg per day), mean increase in Occipito-frontal circumference (in cm per week) and mean increase in length (in cm per week)

时间窗: Admission till discharge from the neonatal intensive care unit

次要结局

  • a.Time to achieve and sustain full feeding for at least 5 successive days(b.Time to regain birth weight)

研究者

发起方
Vishal Vishnu Tewari
申办方类型
Other [self]

研究点 (1)

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