Sodium Supplementation and Growth in Very Low Birth Weight Infants
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2017 |
| Start Date: | October 2009 |
| End Date: | January 2011 |
Impact of Early Postnatal Sodium Supplementation on Weight Gain in Very Low Birth Weight Infants
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.
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.
This is a randomized, blinded, placebo-controlled trial in infants born at less than 32 weeks
gestation, who are admitted to the Newborn Intensive Care Unit at University of Cincinnati
Medical Center, Cincinnati, Ohio. Infants are randomized to receive either 4 meq/kg/day
supplemental sodium or an equal amount of sterile water on days of life 7-35. Institutional
data from 2008 revealed that a sample size of 56 infants completing the study will detect a
15% difference in the primary outcome of weight gain with 80% power and an alpha error of
0.05. Allowing that 33% drop-out rate (infants may be transferred to another hospital,
expire, or be discharged prior to day of life 35), we choose to randomize 75 infants. Calorie
intake, serum sodium, weight gain, urine sodium were monitored weekly till 35 days of life or
discharge. Infants were assessed for common morbidities associated with prematurity including
bronchopulmonary dysplasia, systemic hypertension, late-onset sepsis, necrotizing
enterocolitis and retinopathy of prematurity.
gestation, who are admitted to the Newborn Intensive Care Unit at University of Cincinnati
Medical Center, Cincinnati, Ohio. Infants are randomized to receive either 4 meq/kg/day
supplemental sodium or an equal amount of sterile water on days of life 7-35. Institutional
data from 2008 revealed that a sample size of 56 infants completing the study will detect a
15% difference in the primary outcome of weight gain with 80% power and an alpha error of
0.05. Allowing that 33% drop-out rate (infants may be transferred to another hospital,
expire, or be discharged prior to day of life 35), we choose to randomize 75 infants. Calorie
intake, serum sodium, weight gain, urine sodium were monitored weekly till 35 days of life or
discharge. Infants were assessed for common morbidities associated with prematurity including
bronchopulmonary dysplasia, systemic hypertension, late-onset sepsis, necrotizing
enterocolitis and retinopathy of prematurity.
Inclusion Criteria:
- infants born at less than 32 weeks postmenstrual age
Exclusion Criteria:
- infants with major malformations deemed incompatible with life disease states
characterized by edema renal failure, defined as an increase in serum creatinine by
0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour
We found this trial at
1
site
University of Cincinnati Medical Center Opening in 1823 as the country
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