Early Sodium Intake in Preterm Newborns

Hospital del Niño "Dr. Federico Gomez Santos"

Status and phase: Completed; Phase 4

Conditions: Premature; Hyponatremia

Treatments: Drug: Sodium < 1mEq/kg/day; Drug: Sodium 5mEq/kg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT04035564

01/03/18N01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants <35 Weeks gestation

Exclusion criteria

• Urinary malformations
• Congenital abdominal wall defect
• Intestinal atresia / obstruction
• Congenital heart defect

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Sodium < 1mEq/kg/day

Active Comparator group

Description:

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

Treatment:

Drug: Sodium < 1mEq/kg/day

Sodium 5mEq/kg/day

Experimental group

Description:

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

Treatment:

Drug: Sodium 5mEq/kg/day