NCT04035564

Early Sodium Intake in Preterm Newborns

Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hospital del Niño "Dr. Federico Gomez Santos" · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized controlled trial in infants less than 35 weeks gestation admitted to the Newborn Intensive Care Unit at Children Hospital in Saltillo Coahuila Mexico. Infants receive at 24 hours of life; sodium (5mEq/kg/day) versus less than 1mEq/kg/day. Weight, serum and urine sodium, serum chloride, serum and urine creatinine, serum chloride, bicarbonate and glucose are monitored daily during the first 3 days of life. Patients are assessed for hyponatremia, hypernatremia, weight change, sepsis, necrotizing enterocolitis and intraventricular hemorrhage.

Conditions

• Hyponatremia
• Premature

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-30
• Primary completion: 2020-03-02
• Completion: 2020-03-20
• First posted: 2019-07-29
• Last updated: 2020-04-21
• Results posted: 2020-04-08

Locations

1 site across 1 country: Mexico