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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01795638
Recruitment Status : Terminated (The unit's standard nutrition practices change which impacted our methodology.)
First Posted : February 21, 2013
Last Update Posted : February 21, 2013
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Prematurity Drug: Sodium chloride Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Impact of Early Postnatal Sodium Supplementation on Weight Gain in Very Low Birth Weight Infants
Study Start Date : October 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


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 Name: Sterile Water




Primary Outcome Measures :
  1. Weight gain at six weeks of age [ Time Frame: 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


Secondary Outcome Measures :
  1. body length at six weeks of age [ Time Frame: six weeks of age ]
    The percentage change in body length between the two study arms will be analyzed

  2. Head circumference [ Time Frame: six weeks of age ]
    The percentage increase in head circumference will be compared between the two groups.

  3. Mean systolic blood pressure [ Time Frame: 36 weeks post-conceptual age ]
    Systolic blood pressures at 36 weeks post-conceptual age will be compared between the two groups

  4. chronic diuretic therapy [ Time Frame: patients will be followed during birth hospital stay; an expected average of 3 months of age ]
    The incidence of chronic diuretic therapy will be compared between the two groups

  5. late-onset sepsis [ Time Frame: patients will be followed during birth hospitalization; an expected average of 3 months of age ]
    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.

  6. necrotizing enterocolitis [ Time Frame: patients will be followed during birth hospitalization; an expected average of 3 months of age ]
    The incidence of Bell stage II or greater necrotizing enterocolitis after the second week of life will be compared between the two groups

  7. chronic lung disease [ Time Frame: 36 weeks post-mentrual age ]
    The incidence of chronic lung disease, defined as respiratory support at 36 weeks postmenstrual age will be compared between the two groups

  8. mortality [ Time Frame: patients will be followed during birth hospitalization; an expected 3 months of age ]
    The incidence of death will be compared between the two study arms


Other Outcome Measures:
  1. urine sodium as a predictor for hyponatremia [ Time Frame: days of life 7-35. ]
    The ability of urine sodium values < 20mmol/L to predict serum sodium values <135mg/dL will be determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795638


Locations
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United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Investigators
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Study Director: Henry T Akinbi, MD Cincinnati Childrens Hospital Medical Center

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01795638    
Other Study ID Numbers: 09-07-28-07
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013
Keywords provided by Children's Hospital Medical Center, Cincinnati:
anthropometrics
weight
nutrition
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms