Physiologic Approach to Sodium Supplementation in Premature Infants
CompletedPhase 4Results postedLast updated 22 November 2024
What this trial tests
Phase 4 trial testing Sodium supplementation guided by urine sodium concentration algorithm in Postnatal Growth Disorder in 90 participants. Completed in 15 August 2023.
Adults 7 Days to 16 Days, any sex, with Postnatal Growth Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Somatic Growth (Weight)Primary· between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Group
Value
95% CI
Control
0.04
± 0.63
Sodium Supplementation Algorithm
0.16
± 0.41
Change in Somatic Growth (Length)Primary· between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant length is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Group
Value
95% CI
Control
-0.34
± 0.66
Sodium Supplementation Algorithm
-0.48
± 0.48
Change in Somatic Growth (Head Circumference)Primary· between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant head circumference is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Group
Value
95% CI
Control
0.60
± 0.88
Sodium Supplementation Algorithm
0.54
± 0.57
Change in Somatic Growth (Weight) at Discharge/TransferSecondary· between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Group
Value
95% CI
Control
0.04
± 0.80
Sodium Supplementation Algorithm
0.24
± 0.76
Change in Somatic Growth (Weight) at Discharge/TransferSecondary· between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).
evaluated by the change in kilograms
Group
Value
95% CI
Control
2.00
± 0.76
Sodium Supplementation Algorithm
2.14
± 0.82
Change in Somatic Growth (Length) at Discharge/TransferSecondary· between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant length is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Group
Value
95% CI
Control
-0.39
± 0.96
Sodium Supplementation Algorithm
0.92
± 8.56
Change in Somatic Growth (Head Circumference) at Discharge/TransferSecondary· between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant head circumference is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Group
Value
95% CI
Control
1.03
± 1.07
Sodium Supplementation Algorithm
2.07
± 7.39
Received Diuretic TherapySecondary· between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
number of participants who received diuretic therapy
Group
Value
95% CI
Control
7
Sodium Supplementation Algorithm
11
Duration of Mechanical VentilationSecondary· from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
days on assisted ventilation
Group
Value
95% CI
Control
12.60
± 44.38
Sodium Supplementation Algorithm
8.74
± 16.08
Need for Supplemental Oxygen at DischargeSecondary· assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
supplemental oxygen requirement
Group
Value
95% CI
Control
7
Sodium Supplementation Algorithm
13
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)Secondary· determined at 36 weeks post-menstrual age
Jenson definition of bronchopulmonary dysplasia (BPD), rated 0 - 3; with 0 being no BPD and higher numbers being more severe disease
Group
Value
95% CI
Control
16
Sodium Supplementation Algorithm
15
Control
11
Sodium Supplementation Algorithm
10
Control
12
Sodium Supplementation Algorithm
16
Control
4
Sodium Supplementation Algorithm
2
Retinopathy of Prematurity ≥ Stage 3Secondary· assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Number of participants with Retinopathy of prematurity ≥ Stage 3 as diagnosed by examination of an Ophthalmologist finding abnormal retinal blood vessel growth with ridge formation or retinal detachment.
Group
Value
95% CI
Control
4
Sodium Supplementation Algorithm
2
Adverse events — posted to ClinicalTrials.gov
Time frame: from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, \<1500 grams at birth) infants as assessed by discharge weight. This study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 22 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03889197.