Vitamin CNCT06780345
Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis
A study testing Vitamin C in people with Vitamin C and Postoperative, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of intravenous vitamin C infusion on septic mechanically ventilated full-term neonates who underwent surgical interventions regarding mechanical ventilation parameters, time to wean, and the need for inotropic support. Read more about this study
- Who is it for?
- Ages 37 weeks and older
- Conditions the study is for
- Vitamin C, Postoperative, Mechanically Ventilation
- What is being tested?
- Vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 37 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age more than 37 weeks.
- Both sexes.
- Neonates with sepsis are diagnosed both clinically and serologically after any surgical intervention.
Who cannot join
- Major congenital anomalies and Chromosomal abnormalities.
- neonate <37weeks gestation.
- Hypoxic Ischemic Encephalopathy (HIE).
- Neuromuscular diseases.
- Intraventricular hemorrhage (IV Hge).
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effect of intravenous vitamin C infusion on septic mechanically ventilated full-term neonates who underwent surgical interventions regarding mechanical ventilation parameters, time to wean, and the need for inotropic support.
Read the detailed description
Neonatal sepsis is a syndrome featuring non-specific signs and symptoms of systemic infection accompanied by bacteremia in the first 28 days of extrauterine life. This condition is a public health problem that still contributes to mortality and morbidity in neonatal intensive care units (NICUs) in high, as well as low- and middle-income countries.
Vitamins are essential micronutrients with key roles in many biological pathways relevant to sepsis. Some of these relevant biological mechanisms include antioxidant and anti-inflammatory effects, protein and hormone synthesis, energy generation, and regulation of gene transcription.
Vitamin C, ascorbic acid, is a water-soluble essential micronutrient commonly found in plants, especially fruits. When absorbed, it dissociates at physiological pH to form ascorbate, the redox state of the vitamin most commonly found in cells. In addition to being a potent antioxidant, vitamin C is a cofactor for enzymes involved in protein and hormone synthesis, metabolic pathways for energy generation, and regulation of gene transcription.
- Conditions
- Vitamin C, Postoperative, Mechanically Ventilation, Sepsis, Neonate
- Being tested
- Placebo, Vitamin C
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Mechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C.
Vitamin CDrug
Mechanically ventilated neonates will receive the usual protocol of sepsis plus vitamin C with a loading dose of 0.5 gm /kg and a maintenance dose of 0.5 gm /kg/hour adjusted for six hours for 7-10 days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Mechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C. Receives: Drug: Placebo |
| Vitamin C group | Experimental | Mechanically ventilated neonates will receive the usual protocol of sepsis plus vitamin C with a loading dose of 0.5 gm /kg and a maintenance dose of 0.5 gm /kg/hour adjusted for six hours for 7-10 days. Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Duration of mechanical ventilation was recorded from start of ventilation till weaning or death.
Measured: 28 days from the start of ventilation
Secondary outcomes (2)
Need for inotropic support
Need for inotropic support was recorded.
Measured: 28 days from the start of ventilation
Mortality
Mortality was recorded.
Measured: 28 days from the start of ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin CStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohamed Abotaleb, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780345
- Sponsor's protocol ID
- 36264PR117/2/23
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Elmesiry AM, Elsheikh MR, Elshimy KM, Abotaleb AM. Role of vitamin C infusion in postoperative mechanically ventilated neonates with sepsis: a randomized controlled trial. Eur J Pediatr. 2025 Nov 29;184(12):806. doi: 10.1007/s00431-025-06625-4.
PubMed 41315087
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis
- ClinicalTrials.gov ID
- NCT06780345
- Acronym / sponsor ID
- 36264PR117/2/23
- Conditions
- Vitamin C, Postoperative, Mechanically Ventilation, Sepsis, Neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 17 Jan 2025 (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.
This study aims to evaluate the effect of intravenous vitamin C infusion on septic mechanically ventilated full-term neonates who underwent surgical interventions regarding mechanical ventilation parameters, time to wean, and the need for inotropic support.
Detailed description
Neonatal sepsis is a syndrome featuring non-specific signs and symptoms of systemic infection accompanied by bacteremia in the first 28 days of extrauterine life. This condition is a public health problem that still contributes to mortality and morbidity in neonatal intensive care units (NICUs) in high, as well as low- and middle-income countries.
Vitamins are essential micronutrients with key roles in many biological pathways relevant to sepsis. Some of these relevant biological mechanisms include antioxidant and anti-inflammatory effects, protein and hormone synthesis, energy generation, and regulation of gene transcription.
Vitamin C, ascorbic acid, is a water-soluble essential micronutrient commonly found in plants, especially fruits. When absorbed, it dissociates at physiological pH to form ascorbate, the redox state of the vitamin most commonly found in cells. In addition to being a potent antioxidant, vitamin C is a cofactor for enzymes involved in protein and hormone synthesis, metabolic pathways for energy generation, and regulation of gene transcription.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: PlaceboMechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C. |
| Vitamin C group | Experimental | Drug: Vitamin CMechanically ventilated neonates will receive the usual protocol of sepsis plus vitamin C with a loading dose of 0.5 gm /kg and a maintenance dose of 0.5 gm /kg/hour adjusted for six hours for 7-10 days. |
Who may qualify
- Ages
- 37 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 37 weeks.
- Both sexes.
- Neonates with sepsis are diagnosed both clinically and serologically after any surgical intervention.
Key exclusion criteria (5 listed)
- Major congenital anomalies and Chromosomal abnormalities.
- neonate <37weeks gestation.
- Hypoxic Ischemic Encephalopathy (HIE).
- Neuromuscular diseases.
- Intraventricular hemorrhage (IV Hge).
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 |
|---|---|---|
| PlaceboMechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C. | Drug | Control group |
| Vitamin CMechanically ventilated neonates will receive the usual protocol of sepsis plus vitamin C with a loading dose of 0.5 gm /kg and a maintenance dose of 0.5 gm /kg/hour adjusted for six hours for 7-10 days. | Drug | Vitamin C group |
Primary outcome
Duration of mechanical ventilation
Time frame: 28 days from the start of ventilation
Duration of mechanical ventilation was recorded from start of ventilation till weaning or death.
2 secondary outcomes
Need for inotropic support
Time frame: 28 days from the start of ventilation
Mortality
Time frame: 28 days from the start of ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 41315087Elmesiry AM, Elsheikh MR, Elshimy KM, Abotaleb AM. Role of vitamin C infusion in postoperative mechanically ventilated neonates with sepsis: a randomized controlled trial. Eur J Pediatr. 2025 Nov 29;184(12):806. doi: 10.1007/s00431-025-06625-4.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Vitamin C and Postoperative, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of mechanical ventilation (time frame: 28 days from the start of ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780345, which also lists 1 linked publication.
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 17 Jan 2025.