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临床试验/CTRI/2021/03/031643
CTRI/2021/03/031643已完成不适用

Comparison of initiating total enteral feeding versus incremental feeding since birth in stable very low birth weight and small for gestational age babies at or above 32 weeks of gestation on duration of hospital stay

Lokmanya Tilak Municipal Medical college and General Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年3月3日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Duration of hospital stay

研究概览

简要总结

Very low birth weight refers to babies with birth weight in between 1000 to 1499gm. Initiation of enteral feeds for very-low-birth weight (VLBW) infants is often delayed for several days due to concerns about feeding intolerance and necrotizing enterocolitis (NEC). The intestine of small for gestational age neonate has reduced weight, length, wall thickness, villous weight and crypt depth. Pathophysiology of fetal adaptation to chronic hypoxia involves preferential shunting of blood to the brain at the expense of the splanchnic circulation. Earlier studies had very samples from the SGA populations. Early introduction of enteral feeds resulted in early achievement of full feeds and doesn’t appear to increase the risk of NEC. This delay diminishes the functional adaptation of the gastrointestinal tract and may prolong the duration of parenteral nutrition with its attendant infectious and metabolic risks. Early introduction and rapid advancement of enteral feeding in preterm infants improves gut maturity and thus reduces the risk of NEC. So the above study shall test the hypothesis that, early total enteral feeding in these group of babies shall lead to shorter duration of hospital stay and earlier discharge.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • All very low birth weight and small for gestational age babies more than or equal to 32 weeks of gestation with ,Heart rate in between 100 to 180 beats/min, Respiratory rate in between 40 to 60/min, Axillary Temperature in between 36.5 to 37.5 degree C, Capillary filling time of < 3sec, Spo2 ( saturation of oxygen) in between 90 to 95%, BP (blood pressure), normal as per nomograms.

排除标准

  • Requiring resuscitation beyond bag and mask ventilation for 30 seconds.
  • Major congenital anomalies
  • Babies with absent or reverse end diastolic flow in the Umbilical artery Doppler.

结局指标

主要结局

Duration of hospital stay

时间窗: From day of admission to the day of discharge.

次要结局

  • 1.Survival to hospital discharge(2.Number of episodes of Hypoglycemia)

研究者

申办方类型
Government medical college

研究点 (1)

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