Actively Recruiting
Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
Led by Aga Khan University Hospital, Pakistan · Updated on 2024-08-09
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 from parents or legal representatives before starting PN
- Neonates admitted to NICU and receiving PN during the first 28 days of life
- Gestational age less than 33 weeks
You will not qualify if you...
- Infants with inborn errors of metabolism
- Genetic or congenital conditions affecting neurodevelopment or requiring multiple surgeries
- Severe metabolic alkalosis with serum pH above 7.45 and bicarbonate above 25 mEq/L
- Severe hypernatremia with serum sodium levels above 150 mmol/L
- Severe liver failure or syndromic infants with multiple congenital abnormalities and severe perinatal asphyxia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Actively Recruiting
Research Team
G
Gul Ambreen, PhD
CONTACT
A
Adnan Mirza, MBBS
CONTACT
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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