Sodium Supplementation and Growth in Premature NeonatesNCT07350135
Sodium Supplementation and Growth in Premature Neonates
A study testing Sodium supplementation guided by serum sodium and fraction sodium in urine in people with Sodium Supplementation and Growth in Premature Neonates, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Sodium Supplementation and Growth in Premature Neonates
- What is being tested?
- Sodium supplementation guided by serum sodium and fraction sodium in urine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Nov 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm from 28 to 34 weeks gestation, admitted to NICU.
- Birth weight (<2500 gm). Postnatal age ≥7 days
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Sodium Supplementation on Postnatal Growth of Premature Neonates: a Randomised Controlled Clinical Trial
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.
Read the 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].
- Being tested
- Sodium supplementation guided by serum sodium and fraction sodium in urine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium supplementation guided by serum sodium and fraction sodium in urineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | - 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. Receives: Drug: Sodium supplementation guided by serum sodium and fraction sodium in urine |
| - Group B: control group | No intervention | - Group B: control group will not receive above basic maintenance requirements |
What is being measured
The primary outcome is the main question the study is designed to answer.
follow up weight of preterm for 6 weeks
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.
Measured: since birth till the age of 6 weeks postnatally.
Secondary outcomes (1)
Laboratory studies
- 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).
Measured: twice weekly till 6 weeks post natal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start6 Nov 2025
- Primary completion6 Nov 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium Supplementation and Growth in Premature NeonatesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- at least 74 premature neonates (37 in each group) By using Power Analysis and Sample Size Software (PASS 15) (Version 15.0.10) for sample size calculation, setting power at 80%, significance level 0.05 and after reviewing previous study results \[9\] showing that among preterm infants, infants who received sodium supplementation had greater Percentage increase from birth at 6 weeks of age than those who do not (194.9 + 18 versus 182.6 + 19 respectively); Based on that, a sample size of at least 74 Preterm infants (gestational age \<34 weeks and birth weight \<2500 gm) randomly assigned according to gender and gestational age into 2 groups (37 neonate in each group) will be needed.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350135
- Sponsor's protocol ID
- MD122a/2025
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sodium Supplementation on Postnatal Growth of Premature Neonates: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07350135
- Acronym / sponsor ID
- MD122a/2025
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 6 Nov 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- at least 74 premature neonates (37 in each group) By using Power Analysis and Sample Size Software (PASS 15) (Version 15.0.10) for sample size calculation, setting power at 80%, significance level 0.05 and after reviewing previous study results [9] showing that among preterm infants, infants who received sodium supplementation had greater Percentage increase from birth at 6 weeks of age than those who do not (194.9 + 18 versus 182.6 + 19 respectively); Based on that, a sample size of at least 74 Preterm infants (gestational age <34 weeks and birth weight <2500 gm) randomly assigned according to gender and gestational age into 2 groups (37 neonate in each group) will be needed.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Sodium supplementation guided by serum sodium and fraction sodium in urine- 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. |
| - Group B: control group | No intervention | –- Group B: control group will not receive above basic maintenance requirements |
Who may qualify
- Ages
- 7 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm from 28 to 34 weeks gestation, admitted to NICU.
- Birth weight (<2500 gm). Postnatal age ≥7 days
Key exclusion criteria (6 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium supplementation guided by serum sodium and fraction sodium in urineThe 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). | Drug | Group A |
Primary outcome
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.
1 secondary outcome
Laboratory studies
Time frame: twice weekly till 6 weeks post natal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium supplementation guided by serum sodium and fraction sodium in urine in people with Sodium Supplementation and Growth in Premature Neonates, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow up weight of preterm for 6 weeks (time frame: since birth till the age of 6 weeks postnatally.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.