CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Sodium supplementation guided by urine sodium concentration algorithmdrug
Likely dose
Initial 4 mEq/kg/day sodium, with incremental increases of 2 mEq/kg/day based on urine sodium concentration algorithmAI-extracted
Key inclusion· 4
  • ✓Gestational age 25 0/7 to 29 6/7 weeks at birth
  • ✓Birth weight ≥500 grams
  • ✓Admitted to hospital within the first week of life
  • ✓Enrollment by 16 days of age
Key exclusion· 7
  • ✕Admission after the first week of life
  • ✕Major congenital anomalies
  • ✕Structural genitourinary abnormality
  • ✕Renal dysfunction (serum creatinine >1.0 mg/dL or increase ≥0.3 mg/dL between two consecutive recent measurements)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03889197
NCT03889197Phase 4Completed
CompareCT.gov

Physiologic Approach to Sodium Supplementation in Premature Infants

Indiana University·interventional·Posted Mar 26, 2019·Updated Nov 22, 2024

In Brief

A Phase 4 clinical trial evaluating Sodium supplementation guided by urine sodium concentration algorithm for Postnatal Growth Disorder. Completed, enrolled 90 participants across 3 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostnatal Growth Disorder
CountriesUnited States
CollaboratorsThrasher Research Fund

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartJul 1, 2019
Primary CompletionJul 22, 2023
Study CompletionAug 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.3 years ago

Interventions

Sodium supplementation guided by urine sodium concentration algorithmdrug

4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.