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临床试验/CTRI/2024/07/069780
CTRI/2024/07/069780尚未招募4 期

Re-feeding versus discarding gastric residuals in preterm infants less than 37 weeks of gestation - a randomized controlled trial

KEM hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
KEM hospital
入组人数
46
试验地点
1
主要终点
Time to attain full enteral feeds (120ml/kg/day)

研究概览

简要总结

Early achievement of full enteral feeds in preterm infants has shown improved growth, and neurodevelopment and reduced the rate of sepsis. Gastric residual volumes are essential for digestion and gastrointestinal tract motility and maturation. Disposing of the partially digested milk and replacing it with fresh milk for the neonate might heighten the strain on the immature gut of preterm infants, consequently raising the likelihood of feed intolerance. It may create potentially creating an alkaline environment that increases the risk of NEC and late-onset sepsis. Conversely, reintroducing bile-stained or bloodstained gastric residuals during feeding may cause gastric irritation and vomiting and heighten the risk of infection, potentially resulting in NEC, sepsis, or both, when handling and reintroducing gastric contents. It usually depends on the nature and amount of the gastric aspirates. Available data from trials suggests that there is considerable variability in the approach to either refeeding or discarding gastric residual. Studies in neonates are limited. Given the lack of enough evidences from clinical trials, we aim to compare whether re-feeding of gastric residual volumes would reduce the time needed to achieve full enteral feeding in preterm infants and to determine whether the rate of death, duration of hospital stay, occurrence of NEC or feed intolerance would differ between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • any preterm infant less than 37 weeks of gestation will be included after obtaining written informed consent from the parents.

排除标准

  • Any preterm with congenital anomalies.

结局指标

主要结局

Time to attain full enteral feeds (120ml/kg/day)

时间窗: 4 weeks

次要结局

  • Time to regain birth weight (in days)(4 weeks)
  • Rate of weight gain (g/kg/d), linear growth (cm/week), and increase in head(circumference (cm/week) during the initial hospitalization period)
  • Risk of necrotizing enterocolitis (NEC) stage ≥ 2 (modified Bell’s staging) or(spontaneous intestinal perforation (SIP))
  • Duration of hospital stay(8 weeks)
  • Number of days receiving total par enteral nutrition (TPN)(4 weeks)

研究者

发起方
KEM hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anitha Haribalakrishna

Seth G.S. Medical College & KEM Hospital

研究点 (1)

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