NCT06545565 Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
| NCT ID | NCT06545565 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Aga Khan University Hospital, Pakistan |
| Condition | Metabolic Acidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-05-10 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 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
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent obtained by parents/legal representative (according to local regulations) before the initiation of PN. 2. All the neonates who were admitted to the NICU of AKUH and received PN during 28 days of their life. 3. Gestational age \< 33 weeks Exclusion Criteria: 1. Infants with an inborn error of metabolism 2. 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.) 3. 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. 4. Severe Hypernatremia, in critically ill neonates, is defined as persistently high serum sodium levels \> 150 mmol/L 5. Severe liver failure and syndromic infants with multiple congenital abnormalities and severe perinat