Early Sodium Intake in Preterm Newborns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial

Conditions
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Hyponatremia, Premature

Intervention / Treatment
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* Drug: Sodium < 1mEq/kg/day
* Drug: Sodium 5mEq/kg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants <35 Weeks gestation Exclusion Criteria: Urinary malformations Congenital abdominal wall defect Intestinal atresia / obstruction Congenital heart defect

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium < 1mEq/kg/day<br>Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one | Drug: Sodium < 1mEq/kg/day<br>* Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1<br>|
| Experimental: Sodium 5mEq/kg/day<br>Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one | Drug: Sodium 5mEq/kg/day<br>* Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyponatremia | serum sodium <130mEq/L | 72 hours | 
| Hypernatremia | serum sodium >150mEq/L | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Weight Change | The difference between initial weight and 72hrs weight, expressed in percentage of birth weight. | Initial weight (baseline) vs 72 hours | 
| Change in Serum Sodium | The difference between current serum sodium and initial serum sodium | Initial serum sodium (baseline) vs 72 hours | 
| Weight Change | The difference between current weight and initial weight | Initial weight (baseline) vs 72 hours | 
| Number of Participants With Late-onset Sepsis | Positive blood culture and/or 5 days of continuous antimicrobial therapy | Patients will be followed during hospitalization, an expected average of 3 months of age | 
| Number of Participants With Necrotizing Enterocolitis | 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 | Patients will be followed during hospitalization, an expected average of 3 months of age | 
| Number of Participants With Intraventricular Hemorrhage | Bleeding into the brain´s ventricular system (intracranial ultrasound). | Patients will be followed during hospitalization, an expected average of 3 months of age | 
| Mortality | Death during hospitalization. | Patients will be followed during hospitalization, an expected average of 3 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm infant, Sodium, Hyponatremia