Sodium Supplementation and Growth in Very Low Birth Weight Infants (SSALT)

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.

Study Overview

• Status: Terminated
• Conditions: Extreme Immaturity
• Intervention / Treatment: Drug: Sodium chloride; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sodium chloride; Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously.	Drug: Sodium chloride
Placebo Comparator: sterile water; Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously.	Drug: Placebo; sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.; Other Names: Sterile Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain at Six Weeks of Age	Average weight gain in g/kg/day and also as a % birthweight over the first six weeks of the study will be compared between the two study arms	Six weeks of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Length at Six Weeks of Age	The percentage of infants maintaining birth percentile at six weeks between the two study arms will be analyzed	six weeks of age
Head Circumference	The percentage of infants maintaining birth percentile for head circumference will be compared between the two groups.	six weeks of age
Mean Systolic Blood Pressure	Systolic blood pressures at 36 weeks post-conceptual age will be compared between the two groups	36 weeks post-conceptual age
Chronic Diuretic Therapy	The incidence of chronic diuretic therapy will be compared between the two groups	patients will be followed during birth hospital stay; an expected average of 3 months of age
Late-onset Sepsis	The incidence of late-onset sepsis, defined as positive blood culture for credible pathogen and/or 5 days of continuous antimicrobial therapy after the first week of life will be compared between the two groups.	patients will be followed during birth hospitalization; an expected average of 3 months of age
Necrotizing Enterocolitis	The incidence of Bell stage II or greater necrotizing enterocolitis after the second week of life will be compared between the two groups	patients will be followed during birth hospitalization; an expected average of 3 months of age
Chronic Lung Disease	The incidence of chronic lung disease, defined as respiratory support at 36 weeks postmenstrual age will be compared between the two groups	36 weeks post-mentrual age
Mortality	The incidence of death during birth hospitalization will be compared between the two study arms	patients will be followed during birth hospitalization; an expected 3 months of age
Patent Ductus Arteriosus	prolonged Patent Ductus Arteriosus after the second week of life	After the second week of life

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Cincinnati
• Investigators: Study Director: Henry T Akinbi, MD, Cincinnati Childrens Hospital Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 18, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: nutrition; weight; anthropometrics
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 09-07-28-07