Status:
TERMINATED
Sodium Supplementation and Growth in Very Low Birth Weight Infants
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
University of Cincinnati
Conditions:
Extreme Immaturity
Eligibility:
All Genders
7-8 years
Phase:
PHASE4
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 th...
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,...
Eligibility Criteria
Inclusion
- infants born at less than 32 weeks postmenstrual age
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01795638
Start Date
October 1 2009
End Date
January 1 2011
Last Update
September 7 2020
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45229