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Early Sodium Intake in Preterm Newborns

NCT04035564 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-04-21

Study results available
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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.

Conditions

Interventions

DRUG

Sodium < 1mEq/kg/day

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

DRUG

Sodium 5mEq/kg/day

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

Sponsors & Collaborators

  • Hospital del Niño "Dr. Federico Gomez Santos"

    lead OTHER

Principal Investigators

  • Carlos Sanchez, MD · Pediatric Nephrology

  • Ben D Valdes, MD · Neonatology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2020-03-02
Completion
2020-03-20

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035564 on ClinicalTrials.gov