CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Sodium < 1mEq/kg/day +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04035564
NCT04035564Phase 4Completed
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Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial

Hospital del Niño "Dr. Federico Gomez Santos"·interventional·Posted Jul 29, 2019·Updated Apr 21, 2020

In Brief

A Phase 4 clinical trial evaluating Sodium < 1mEq/kg/day and Sodium 5mEq/kg/day for Hyponatremia and Premature. Completed, enrolled 52 participants across 1 site.

Detailed Summary

Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome. There is controversy about the time of initiation and the requirements of sodium in premature infants. Hypothesis: early (24 hours of life) sodium supplementation (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyponatremia, Premature
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 29, 2019
Enrollment StartMar 30, 2018
Primary CompletionMar 2, 2020
Study CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.9 years ago

Interventions

Sodium < 1mEq/kg/daydrug

Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1

Sodium 5mEq/kg/daydrug

Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1