Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
Recruiting
Phase 3
Interventional Study
Metabolic Acidosis
Neonatal Disease
Neonatal Complication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 1 Day – 3 Days
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 200 (estimated)
- Sponsor
- Aga Khan University Hospital, Pakistan · Other
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About This Trial
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…
Trial Locations
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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 Cr…
Contacts