Phase 4
N=52
Early Sodium Intake in Preterm Newborns
Hyponatremia · Premature
Bottom Line
View on ClinicalTrials.gov: NCT04035564 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Hyponatremia — 6; 1 Participants — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium < 1mEq/kg/day (Drug); Sodium 5mEq/kg/day (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hyponatremia |
6; 1 | 0.71 |
| PRIMARY Hypernatremia |
1; 1 | 0.89 |
| SECONDARY % Weight Change |
-9.206; -6.345 | 0.032 sig |
| SECONDARY Change in Serum Sodium |
1.921; 5.71 | 0.107 |
| SECONDARY Weight Change |
-135.43; -96.05 | 0.028 sig |
| SECONDARY Number of Participants With Late-onset Sepsis |
8; 5 | 0.55 |
| SECONDARY Number of Participants With Necrotizing Enterocolitis |
2; 2 | 0.84 |
| SECONDARY Number of Participants With Intraventricular Hemorrhage |
6; 4 | 0.70 |
| SECONDARY Mortality |
5; 2 | 0.33 |
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.
Eligibility Criteria
Inclusion Criteria
- Preterm infants <35 Weeks gestation
Exclusion Criteria
- Urinary malformations
- Congenital abdominal wall defect
- Intestinal atresia / obstruction
- Congenital heart defect
Data sourced from ClinicalTrials.gov (NCT04035564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.