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临床试验/NCT07350135
NCT07350135进行中(未招募)不适用

Impact of Sodium Supplementation on Postnatal Growth of Premature Neonates: a Randomised Controlled Clinical Trial

Ain Shams University0 个研究点目标入组 74 人开始时间: 2025年11月6日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
74

研究概览

简要总结

Primary aim: to assess the impact of late (≥7 days postnatal) sodium supplementation of premature neonates with birth weight less than 2500 gm on their postnatal short-term catch-up growth.

Secondary aim: to find out the effect of this sodium supplementation on fractional excretion of sodium, hemodynamics and prematurity-related short-term neonatal outcomes including morbidities and morality.

详细描述

Preterm birth is a global health problem and the primary contributor to neonatal mortality and morbidity [2].

Poor growth after preterm birth is challenging and arises from a combination of various factors, including nutritional needs, hormonal abnormalities, central nervous system damage, feeding difficulties, and administration of drugs that affect nutrient metabolism [3].

Typically, weight gain in the neonatal period begins after the first week of life, considered a period of physiological weight loss. With a mean period of 10.6 days, preterm neonates experience an average weight gain of 16.7 g/kg per day after reaching their birth weight [4].

The shift from the intra- to the extrauterine environment is associated with significant alternations in water and electrolytes, especially sodium homeostasis. In the early phase, this is primarily marked by decreased extracellular fluid volume and sodium loss. This adaptation becomes considerably more complex in premature infants due to immature kidneys, which lack full regulatory functionality and increased transdermal water loss [5]. Consequently, premature infants are at risk to hypernatremia early in life. In contrast, after the initial postnatal period with skin maturation, these infants become susceptible to hyponatremia because of the inability of the premature kidney to retain salt [6]. This often necessitates high sodium substitution to ensure adequate growth [5].

Sodium plays a crucial role for protein synthesis, bone mineralization, maintenance of extracellular space, and enabling the transport of glucose across the cell membranes [7]. Sodium can be considered a growth factor that stimulates protein synthesis and increase cell mass, and thus inadequate sodium intake can lead to chronic sodium depletion and thus growth failure [1].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
7 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm from 28 to 34 weeks gestation, admitted to NICU.
  • Birth weight (<2500 gm). Postnatal age ≥7 days

排除标准

  • - Major congenital malformations.
  • Congenital heart disease
  • Renal insufficiency (defined as an increase in serum creatinine by ≥0.5 mg/dL/d, urine output <0.5 mL/kg/h) [10].
  • Disease states characterized by fluid retention: as cardiac, hepatic or renal.
  • Receiving diuretic therapy.
  • Full term less than 2500 gm.

研究者

申办方类型
Other
责任方
Sponsor

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