Clinical trial NCT01795638: Sodium Supplementation and Growth in Very Low Birth Weight Infants
Official title: Impact of Early Postnatal Sodium Supplementation on Weight Gain in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Extreme Immaturity
Keywords: anthropometrics
weight
nutrition
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2013-02-21
Enrollment: 53
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight Gain at Six Weeks of Age
timeFrame: Six weeks of age
Secondary outcomes:
measure: Body Length at Six Weeks of Age
timeFrame: six weeks of age
measure: Head Circumference
timeFrame: six weeks of age
measure: Mean Systolic Blood Pressure
timeFrame: 36 weeks post-conceptual age
measure: Chronic Diuretic Therapy
timeFrame: patients will be followed during birth hospital stay; an expected average of 3 months of age
measure: Late-onset Sepsis
timeFrame: patients will be followed during birth hospitalization; an expected average of 3 months of age
measure: Necrotizing Enterocolitis
timeFrame: patients will be followed during birth hospitalization; an expected average of 3 months of age
measure: Chronic Lung Disease
timeFrame: 36 weeks post-mentrual age
measure: Mortality
timeFrame: patients will be followed during birth hospitalization; an expected 3 months of age
measure: Patent Ductus Arteriosus
timeFrame: After the second week of life
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: Henry T Akinbi, MD
role: STUDY_DIRECTOR
References: