The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates. It will also teach about the optimal doses of sodium acetate in PN. The main questions it aims to answer are:
Is the incidence of metabolic acidosis reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? Is the rate of neonatal comorbidities reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? What are the optimal neonatal dosing recommendations/guidelines of sodium acetate in daily PN, which are required to prevent/treat metabolic acidosis in the early life of preterm neonates? Researchers will compare Sodium acetate in PN therapy to sodium chloride in PN to see if Sodium acetate works to prevent and treat metabolic acidosis and associated comorbidities.
Included Participants:
All the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives.
Participants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents/legal representatives (according to local regulations) before the initiation of PN. Gestational age \< 33 weeks Included in the study before 72 hours of life
Written informed consent obtained by parents/legal representative (according to local regulations) before the initiation of PN.
All the neonates who were admitted to the NICU of AKUH and received PN during 28 days of their life.
Gestational age < 33 weeks
Infants with an inborn error of metabolism
Genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.)
Severe metabolic alkalosis, in critically ill neonates, is defined as a persistent elevation of the serum pH above 7.45 and it also involves a primary increase in serum bicarbonate (HCO3-) concentration > 25mEq/L.
Severe Hypernatremia, in critically ill neonates, is defined as persistently high serum sodium levels > 150 mmol/L
Parallel
sodium acetate group will receive sodium acetate in the neonatal PN.
DrugThis group will receive sterile sodium acetate daily in the neonatal PN for the duration the patient will receive parenteral nutrition, a maximum of 28 days of life.
sodium chloride group will receive sodium chloride in the neonatal PN.
DrugThis group will receive sterile sodium chloride daily in the neonatal PN for the duration the patient will receive parenteral nutrition, a maximum of 28 days of life.
metabolic acidosis
Severe metabolic acidosis, in critically ill neonates, is defined as a persistent low Blood pH \< 7.26 and it also involves a primary decrease in serum bicarbonate (HCO3-) concentration \<16 mEq/L\]
Development of Comorbid conditions (Bronchopulmonary dysplasia (BPD), patent ductus arteriosus (PDA), Intraventricular hemorrhage (IVH), Retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), Sepsis and jaundice ).
Duration of ventilation
number of days participant receive ventilatory support
Weight change (gain/loss)
daily weight gain or loss of the participants in grams (g)
use of inotropes, plasma volume expanders and sodium bicarbonate therapy
total number of days participants required inotropic support
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