NCT07350135

Sodium Supplementation and Growth in Premature Neonates

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 7 Days – 28 Days
• Healthy volunteers: Accepted

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.

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\[1,8\].

Conditions

• Sodium Supplementation and Growth in Premature Neonates

Interventions

Type	Name	Description
DRUG	Sodium supplementation guided by serum sodium and fraction sodium in urine	The Study population will be stratified according to gender and gestational age and randomly assigned into 2 groups: * Group A: will receive sodium supplementation with a moderate dose (4 mEq/kg/day) above basic maintenance requirements starting from 7 days to 28 days after birth. Sodium will be supplemented in the form of hypertonic saline provided either parenteral (added to maintenance intravenous fluid) or enteral, if oral intake exceeds 100 ml/kg/day (divided and added to feds every 6 hours) \[9\] (withhold supplementation if the serum sodium reaches 150 mmol/L, or development of vomiting or diarrhea with oral supplementation). * Group B: control group will receive basic maintenance requirements of the sodium supplementation (3mEq/kg/day).

Timeline

• Start date: 2025-11-06
• Primary completion: 2028-11-06
• Completion: 2028-12-30
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Egypt