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Search / Trial NCT06545565

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

Launched by AGA KHAN UNIVERSITY HOSPITAL, PAKISTAN · Aug 7, 2024

Trial Information

Current as of June 01, 2025

Recruiting

Keywords

Metabolic Acidosis Sodium Acetate Neonates Parenteral Nutrition

ClinConnect Summary

This clinical trial is studying whether using sodium acetate instead of sodium chloride in the nutrition given to preterm babies can help prevent a condition called metabolic acidosis, which is a buildup of acid in the body. Metabolic acidosis can lead to other health problems, so researchers want to see if sodium acetate can reduce the risk of this condition and its related complications. The trial will also help determine the best amounts of sodium acetate to use in the nutrition for these infants.

To participate in this study, babies must be born before 33 weeks of pregnancy and receive specific nutrition in the hospital's Neonatal Intensive Care Unit (NICU) within the first few days of life. Parents or legal guardians will need to give written consent for their baby to join the trial. Throughout the study, some babies will receive sodium acetate while others will receive the standard sodium chloride. The researchers will closely monitor the babies' health to see how well each treatment works. This important research aims to improve care for preterm infants and reduce the risk of complications from metabolic acidosis.

Gender

ALL

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 perinatal asphyxia
  • -

About Aga Khan University Hospital, Pakistan

Aga Khan University Hospital (AKUH) in Pakistan is a leading tertiary care institution renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, AKUH adheres to the highest ethical standards and regulatory compliance, fostering an environment that prioritizes patient safety and scientific integrity. The hospital collaborates with a multidisciplinary team of healthcare professionals and researchers to explore cutting-edge therapies and interventions, contributing significantly to medical knowledge and improved patient outcomes in the region. With state-of-the-art facilities and a focus on evidence-based medicine, AKUH plays a vital role in enhancing the quality of healthcare in Pakistan and beyond.

Locations

Karachi, Sindh, Pakistan

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported