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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
52
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
Hospital del Niño Dr Federico Gomez Santos
Saltillo, Coahuila, Mexico
Hyponatremia
serum sodium \<130mEq/L
Time frame: 72 hours
Hypernatremia
serum sodium \>150mEq/L
Time frame: 72 hours
% Weight Change
The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.
Time frame: Initial weight (baseline) vs 72 hours
Change in Serum Sodium
The difference between current serum sodium and initial serum sodium
Time frame: Initial serum sodium (baseline) vs 72 hours
Weight Change
The difference between current weight and initial weight
Time frame: Initial weight (baseline) vs 72 hours
Number of Participants With Late-onset Sepsis
Positive blood culture and/or 5 days of continuous antimicrobial therapy
Time frame: 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
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Time frame: 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).
Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age
Mortality
Death during hospitalization.
Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age