Early Sodium Intake in Preterm Newborns

Phase 4

Completed

• Conditions: Hyponatremia; Premature
• Interventions: Drug: Sodium < 1mEq/kg/day; Drug: Sodium 5mEq/kg/day

• Registration Number: NCT04035564
• Lead Sponsor: Hospital del Niño "Dr. Federico Gomez Santos"

Brief 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.

Study Timeline

• Study Start: 2018-03-30
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-20
• Results First Submitted: 2020-03-25
• Results First Submitted QC: 2020-03-25
• Status Verified: 2020-04
• Results First Posted: 2020-04-08
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Preterm infants <35 Weeks gestation

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium < 1mEq/kg/day	Sodium < 1mEq/kg/day	Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
Sodium 5mEq/kg/day	Sodium 5mEq/kg/day	Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one

Primary Outcome Measures

Name	Time	Method
Hyponatremia	72 hours	serum sodium \<130mEq/L
Hypernatremia	72 hours	serum sodium \>150mEq/L

Secondary Outcome Measures

Name	Time	Method
Mortality	Patients will be followed during hospitalization, an expected average of 3 months of age	Death during hospitalization.
% Weight Change	Initial weight (baseline) vs 72 hours	The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.
Number of Participants With Late-onset Sepsis	Patients will be followed during hospitalization, an expected average of 3 months of age	Positive blood culture and/or 5 days of continuous antimicrobial therapy
Change in Serum Sodium	Initial serum sodium (baseline) vs 72 hours	The difference between current serum sodium and initial serum sodium
Number of Participants With Intraventricular Hemorrhage	Patients will be followed during hospitalization, an expected average of 3 months of age	Bleeding into the brain´s ventricular system (intracranial ultrasound).
Weight Change	Initial weight (baseline) vs 72 hours	The difference between current weight and initial weight
Number of Participants With Necrotizing Enterocolitis	Patients will be followed during hospitalization, an expected average of 3 months of age	Number of patients with Bell stage II or greater necrotizing enterocolitis; Bell's Staging: Stage II A: Gastrointestinal signs: Increasing gastric aspirates, mild abdominal distention, fecal occult blood, absent bowel sounds.; Systemic signs: Temperature instability, apnea, bradycardia, lethargy. Radiological findings: Intestinal dilatation, ileus, pneumatosis intestinalis.; Stage II B: Gastrointestinal signs: As stage IIA plus abdominal tenderness. Systemic signs: As stage IIA plus metabolic acidosis and thrombocytopenia. Radiological findings: As stage IIA plus portal vein gas and ascites.; Stage III A: Gastrointestinal signs: As stage IIB plus marked abdominal tenderness and generalised peritonitis.; Systemic signs: As stage IIB plus hypotension and severe apnea. Radiological findings: As stage IIB; Stage III B: Gastrointestinal signs: As stage IIIA As stage IIIA As stage IIIA plus pneumoperitoneum

Trial Locations

Locations (1)

Hospital del Niño Dr Federico Gomez Santos; 🇲🇽 Saltillo, Coahuila, Mexico