Trial Comparing Sodium Acetate Versus Sodium Chloride in Parenteral Nutrition to Prevent Metabolic Acidosis in Preterm Babies Under 33 Weeks

What this Trial Is About

Researchers are evaluating whether adding sodium acetate to parenteral nutrition PN can prevent and treat metabolic acidosis and related complications in preterm newborns. This phase III randomized controlled trial compares sodium acetate with the standard sodium chloride in PN during the first weeks of life. The study also aims to determine the best dosing guidelines for sodium acetate to manage metabolic acidosis in these vulnerable infants. The trial has two groups one receiving daily sodium acetate in their PN and the other receiving sodium chloride, the usual care. Treatment begins within 72 hours of birth and continues for up to 28 days while the neonates are in the neonatal intensive care unit NICU. This open-label study is conducted at the Aga Khan University Hospital NICU, where all participants receive PN according to their assigned group. During the study, researchers will collect detailed data including blood pH and bicarbonate levels on specific days up to 28 days of life. They will also monitor for neonatal complications like bronchopulmonary dysplasia, patent ductus arteriosus, infections, and survival rates. Daily weight changes, use of medications like inotropes, and ventilation duration will be recorded. These assessments help understand the impact of sodium acetate in PN on metabolic acidosis and overall health outcomes in preterm neonates.

Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition