Actively Recruiting
Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition A Randomized Controlled Trial
Led by Aga Khan University Hospital, Pakistan · Updated on 2024-08-09
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding sodium acetate to parenteral nutrition (PN) can prevent and treat metabolic acidosis and related complications in preterm newborns. This phase III randomized controlled trial compares sodium acetate with the standard sodium chloride in PN during the first weeks of life. The study also aims to determine the best dosing guidelines for sodium acetate to manage metabolic acidosis in these vulnerable infants. The trial has two groups: one receiving daily sodium acetate in their PN and the other receiving sodium chloride, the usual care. Treatment begins within 72 hours of birth and continues for up to 28 days while the neonates are in the neonatal intensive care unit (NICU). This open-label study is conducted at the Aga Khan University Hospital NICU, where all participants receive PN according to their assigned group. During the study, researchers will collect detailed data including blood pH and bicarbonate levels on specific days up to 28 days of life. They will also monitor for neonatal complications like bronchopulmonary dysplasia, patent ductus arteriosus, infections, and survival rates. Daily weight changes, use of medications like inotropes, and ventilation duration will be recorded. These assessments help understand the impact of sodium acetate in PN on metabolic acidosis and overall health outcomes in preterm neonates.
CONDITIONS
Brief Title
Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained by parents or legal representatives before starting parenteral nutrition.
- Neonates admitted to the NICU and receiving parenteral nutrition during the first 28 days of life.
- Gestational age less than 33 weeks.
- Enrollment before 72 hours of life.
You will not qualify if you...
- Infants with an inborn error of metabolism.
- Genetic or congenital conditions affecting neurodevelopment or requiring multiple surgeries.
- Severe metabolic alkalosis defined as serum pH above 7.45 and bicarbonate concentration over 25 mEq/L.
- Severe hypernatremia with serum sodium levels above 150 mmol/L.
- Severe liver failure, syndromic infants with multiple congenital abnormalities, or severe perinatal asphyxia.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 72 hours after birth
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 28 days or until discharge or death
Participants receive either sodium acetate or sodium chloride daily as part of their parenteral nutrition to prevent metabolic acidosis during the neonatal period.
Daily administration while receiving parenteral nutrition with blood tests on days 1, 2-7, 10, 13, 16, 20, 25, and 28 of life
Duration - Up to 4 weeks
Participants are monitored for development of comorbid conditions, survival, and other clinical outcomes up to 4 weeks of life.
Assessments up to 28 days or until discharge or death
Trial Site Locations
Total: 1 location
1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Actively Recruiting
Research Team
G
Gul Ambreen, PhD
A
Adnan Mirza, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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