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N-acetylcysteine as Adjunct Therapy in Neonatal Sepsis
NCT07380347Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2026
- Primary completion
- Jul 2026
- Sponsor
- Ain Shams University
- Modality
- Small Molecules
- Drugs
- acetylcysteine
- Conditions
- neonatal sepsis
01
Overview
Phase 3, randomised trial of acetylcysteine in neonatal sepsis (2 arms), sponsored by Ain Shams University. Primary endpoint: Neonatal Sepsis Classification Based on Predefined Clinical and Laboratory Criteria at 3 days. Planned start Feb 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- Randomized
Interventional Group
N-acetylcysteine + standard care
Control Group
Placebo (Normal Saline) + standard care
03
Who it enrols
Near-term and term (>= 32 gestational weeks) neonates up to 28 days of life diagnosed with sepsis.
04
Endpoints
Primary
Neonatal Sepsis Classification Based on Predefined Clinical and Laboratory Criteria
Secondary
Neonatal Sequential Organ Failure Assessment Score
Malondialdehyde levels
Recording of Safety and Tolerability of NAC
Incidence of Multiple Organ Dysfunction Syndrome
Length of Hospital Stay
Recording of Mortality
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