Status:
RECRUITING
Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
Lead Sponsor:
Aga Khan University Hospital, Pakistan
Conditions:
Metabolic Acidosis
Neonatal Disease
Eligibility:
All Genders
1-3 years
Phase:
PHASE3
Brief Summary
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 als...
Detailed Description
Background Providing optimal nutritional support to extremely preterm and very low birth weight (VLBW) infants is still very much a challenge, as enteral feeding is generally delayed due to the premat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Severe liver failure and syndromic infants with multiple congenital abnormalities and severe perinatal asphyxia
- \-
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 10 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06545565
Start Date
July 10 2024
End Date
May 10 2025
Last Update
August 9 2024
Active Locations (1)
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1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800