Using sodium acetate instead of sodium chloride in nutrition for preterm babies to prevent metabolic acidosis
Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition - A Randomized Controlled Trial. (PROTECT Trial)
This study is testing if using sodium acetate instead of sodium chloride in nutrition can help prevent and treat metabolic acidosis in preterm babies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Day to 3 Days |
| Sex | All |
| Sponsor | Aga Khan University Hospital, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06545565 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether the addition of sodium acetate to parenteral nutrition (PN) can effectively prevent and treat metabolic acidosis in preterm neonates. The study will compare the incidence of metabolic acidosis and associated comorbidities in infants receiving sodium acetate versus those receiving the standard sodium chloride in PN. Additionally, it seeks to establish optimal dosing guidelines for sodium acetate in this vulnerable population. The trial will be conducted at Aga Khan University Hospital, focusing on neonates with a gestational age of less than 33 weeks.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm neonates admitted to the NICU with a gestational age of less than 33 weeks who require parenteral nutrition.
Not a fit: Patients with inborn errors of metabolism, severe congenital conditions, or severe metabolic alkalosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of metabolic acidosis and improve health outcomes for preterm neonates.
How similar studies have performed: While the use of sodium acetate in PN is a novel approach at this institution, similar studies have shown promising results in other settings.
Eligibility criteria
Show full inclusion / exclusion 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 \-
Where this trial is running
Karachi, Sindh
- Aga Khan University Hospital — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Study coordinator: Gul Ambreen, PhD
- Email: gul.ambreen@aku.edu
- Phone: +92 3002402035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.