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NCT Number: NCT07350135

Sodium Supplementation and Growth in Premature Neonates

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.

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Key information

Age range

7 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eldemerdash Hospital

Cairo, Egypt

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • - 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.

Treatment and study plan

Sodium supplementation guided by serum sodium and fraction sodium in urine

Drug

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).

Primary outcomes

  1. follow up weight of preterm for 6 weeks

    Time frame: since birth till the age of 6 weeks postnatally.

    measuring birth weight of the neonate Initially and then twice weekly in grams (g) and z-scores will be calculated using the Fenton Preterm Growth Chart for boys or girls. This will continue till the age of 6 weeks postnatal life.

Secondary outcomes

  1. Laboratory studies

    Time frame: twice weekly till 6 weeks post natal

    • Serum sodium concentration: initial level, then twice weekly to report hyponatremia (defined as serum sodium <130 mmol/L) or hypernatremia (defined as serum sodium ≥ 150 mmol/L).
    • Fractional Excretion of Sodium: initial level, then after two weeks from sodium supplementation calculated by measuring creatinine and sodium levels in the blood and urine simultaneously [(urinary sodium × serum creatinine)/ (urinary creatinine × serum sodium)×100).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.