Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:03 AM
Study NCT ID:
NCT07350135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Supplementation and Growth in Premature Neonates
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Impact of Sodium Supplementation on Postnatal Growth of Premature Neonates: a Randomised Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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 \[1\].
The European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee of Nutrition recently issued updated recommendations for sodium intake of 3-8 mEq/kg/day for preterm infants during the first few months of birth\[1,8\].
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 \[1\].
The European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee of Nutrition recently issued updated recommendations for sodium intake of 3-8 mEq/kg/day for preterm infants during the first few months of birth\[1,8\].
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: