Neonatal SepsisPhase 3NCT07380347
Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal Sepsis
A Phase 3 study testing N-Acetyl Cysteine (NAC) and Normal Saline in people with Neonatal Sepsis, run by Ain Shams University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- N-Acetyl Cysteine (NAC) and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Critical major congenital anomalies that are incompatible with first 28 days vitality.
- Hypersensitivity to NAC
- Parents or guardians who decline consent.
About this study
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.
- Conditions
- Neonatal Sepsis
- Being tested
- N-Acetyl Cysteine (NAC), Normal Saline
- Keywords
- NAC, Neonatal Sepsis, MDA, Sepsis Score, nSOFA
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl Cysteine (NAC)Drug
A group of 25 neonates 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. Each dose will be infused over 60 min
Normal SalineOther
A group of 25 neonates as controls will receive Normal saline in the same volume of the diluted NAC.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Active comparator | 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. Receives: Drug: N-Acetyl Cysteine (NAC) |
| Control Group | Placebo comparator | 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. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Sepsis Classification Based on Predefined Clinical and Laboratory Criteria
Neonates will be classified into one of four categories: highly probable sepsis, probable sepsis, possible sepsis, or no sepsis, according to predefined clinical and laboratory criteria.
Classification is based on:
Number of sepsis-related clinical signs (including temperature instability, apnea, need for oxygen or ventilation, tachycardia or bradycardia, hypotension, feeding intolerance, abdominal distension, and necrotizing enterocolitis) C-reactive protein (CRP) level (cutoff 5 mg/mL) Presence of altered hematological parameters (white blood cell count, absolute neutrophil count, and platelet count) Blood culture results This outcome represents a categorical diagnostic classification, not a numerical scoring scale.
Measured: From enrollment to the end of treatment at 3 days
Secondary outcomes (6)
Neonatal Sequential Organ Failure Assessment (nSOFA) Score
The Neonatal Sequential Organ Failure Assessment (nSOFA) score ranges from 0 to 15, with higher scores indicating worse organ dysfunction. The nSOFA score will be recorded during the study period.
Measured: From enrollment to the end of treatment (3 days)
Malondialdehyde (MDA) levels.
Serum malondialdehyde (MDA) level will be measured as a biomarker of oxidative stress using a validated laboratory method and reported in nmol/mL.
Measured: From enrollment to the end of treatment at 3 days
Recording of Safety and Tolerability of NAC
Safety and tolerability will be assessed by monitoring adverse events related to N-acetylcysteine administration throughout the study period.
Measured: From day 1 to day 28.
Incidence of Multiple Organ Dysfunction Syndrome (MODS)
The occurrence of multiple organ dysfunction syndrome (MODS) will be recorded as a binary outcome (yes/no) during the study period.
Measured: From day 1 to day 28.
Length of Hospital Stay
Length of hospital stay will be calculated as the number of days from admission to hospital discharge.
Measured: From day 1 to day 28.
Recording of Mortality
Mortality will be assessed by recording the number of death cases in each study group during the neonatal period.
Measured: From day 1 to day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380347
- Sponsor's protocol ID
- FMASU MS 661/2025
- Status last verified
- Oct 2025
- First submitted
- 20 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT07380347
- Acronym / sponsor ID
- FMASU MS 661/2025
- Conditions
- Neonatal Sepsis
- Keywords
- NAC, Neonatal Sepsis, MDA, Sepsis Score, nSOFA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Active comparator | Drug: N-Acetyl Cysteine (NAC)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. |
| Control Group | Placebo comparator | Other: Normal SalineA 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. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Critical major congenital anomalies that are incompatible with first 28 days vitality.
- Hypersensitivity to NAC
- Parents or guardians who decline consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl Cysteine (NAC)A group of 25 neonates 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. Each dose will be infused over 60 min | Drug | Interventional Group |
| Normal SalineA group of 25 neonates as controls will receive Normal saline in the same volume of the diluted NAC. | Other | Control Group |
Primary outcome
Neonatal Sepsis Classification Based on Predefined Clinical and Laboratory Criteria
Time frame: From enrollment to the end of treatment at 3 days
Neonates will be classified into one of four categories: highly probable sepsis, probable sepsis, possible sepsis, or no sepsis, according to predefined clinical and laboratory criteria. Classification is based on: Number of sepsis-related clinical signs (including temperature instability, apnea, need for oxygen or ventilation, tachycardia or bradycardia, hypotension, feeding intolerance, abdominal distension, and necrotizing enterocolitis) C-reactive protein (CRP) level (cutoff 5 mg/mL) Presence of altered hematological parameters (white blood cell count, absolute neutrophil count, and platelet count) Blood culture results This outcome represents a categorical diagnostic classification, not a numerical scoring scale.
6 secondary outcomes
Neonatal Sequential Organ Failure Assessment (nSOFA) Score
Time frame: From enrollment to the end of treatment (3 days)
Malondialdehyde (MDA) levels.
Time frame: From enrollment to the end of treatment at 3 days
Recording of Safety and Tolerability of NAC
Time frame: From day 1 to day 28.
Incidence of Multiple Organ Dysfunction Syndrome (MODS)
Time frame: From day 1 to day 28.
Length of Hospital Stay
Time frame: From day 1 to day 28.
Recording of Mortality
Time frame: From day 1 to day 28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-Acetyl Cysteine (NAC) and Normal Saline in people with Neonatal Sepsis, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Sepsis Classification Based on Predefined Clinical and Laboratory Criteria (time frame: From enrollment to the end of treatment at 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.