Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal Sepsis

Ain Shams University

Status and phase: Not yet enrolling; Phase 3

Conditions: Neonatal Sepsis

Treatments: Drug: N-Acetyl Cysteine (NAC); Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07380347

FMASU MS 661/2025

Details and patient eligibility

About

Neonatal sepsis (NS) is a life-threatening condition characterized by systemic inflammation in response to infection during the first 28 days of life. Nowadays, it is generally acknowledged that one of the critical pathogenic mechanisms involved in neonatal sepsis is oxidative stress, which plays a critical role in amplifying inflammation and cellular injury. During sepsis, activated immune cells such as neutrophils and macrophages produce large amounts of ROS and RNS as part of the antimicrobial defense. Also, IL-6 and IL-8 are the main cytokines involved in the initiation of the sepsis cascade in the newborn, following that, several oxidative stress-related pathways are activated through different mechanisms, triggering the initiation of a self-maintaining "sepsis redox cycle" finally leading to cell oxidative damage and mitochondria dysfunction. One of the major consequences of oxidative stress is lipid peroxidation, in which ROS attack polyunsaturated fatty acids (PUFAs) in cellular membranes which leads to membrane dysfunction and cellular injury. One of the major consequences of oxidative stress is lipid peroxidation, in which ROS attack polyunsaturated fatty acids (PUFAs) in cellular membranes which leads to membrane dysfunction and cellular injury. Elevated levels of MDA in neonatal sepsis are associated with increased oxidative damage and worse clinical outcomes, making it a valuable marker for assessing the oxidative burden in sepsis. N-acetylcysteine (NAC) has the ability to replenish intracellular glutathione levels and neutralize ROS makes it promising as adjunct therapy in neonatal sepsis. administering NAC to neonates with sepsis could potentially improve clinical outcomes by reducing oxidative damage through replenishing glutathione and scavenging free radicals result in reduction of MDA level which is a biomarker for lipid peroxidation and oxidative damage, preserving organ function, and preventing the progression to severe complications like MODS. NAC efficacy in neonatal sepsis is not studied yet, and it is unknown whether NAC is beneficial as adjunct therapy for neonatal sepsis or not.

The aim of this study is to evaluate the efficacy of N-acetylcysteine as an adjunctive therapy in neonatal sepsis by assessing clinical improvement using the sepsis score and nSOFA score, reduction of oxidative stress through changes in malondialdehyde (MDA) levels, and its impact on the length of hospital stay and mortality.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age at admission: Near-term and term (≥ 32 gestational weeks) neonates up to 28 days of life.
• Neonates diagnosed with sepsis: diagnosis of sepsis based on high probable sepsis (HPS) and probable sepsis (PRS) according to the criteria employed for defining the sepsis score.

Exclusion criteria

• Critical major congenital anomalies that are incompatible with first 28 days vitality.
• Hypersensitivity to NAC
• Parents or guardians who decline consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Interventional Group

Active Comparator group

Description:

A group of 25 neonates who will receive (12.5 mg/kg for preterm and 25 mg/kg for full-term neonates) of NAC intravenously every 12 hours for 3 days. in addition to the standard neonatal sepsis care in the unit.

Treatment:

Drug: N-Acetyl Cysteine (NAC)

Control Group

Placebo Comparator group

Description:

A group of 25 neonate controls will receive Normal saline in the same volume of the diluted NAC. In addition to the standard neonatal sepsis care in the unit.

Treatment:

Other: Normal Saline