drugset / Trial / NCT01795638

Sodium Supplementation and Growth in Very Low Birth Weight Infants

NCT01795638

RandomizedParallel-groupDouble-blindPrevention

Summary

Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. Our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. Secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.

Timeline

Start
2009-10
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium chloride Unknown 1 meq Intravenous

Indications

No indication recorded.