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Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis

Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06780345
Enrollment
50
Registered
2025-01-17
Start date
2023-02-01
Completion date
2023-08-01
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Ventilation, Neonate, Postoperative, Sepsis, Vitamin C

Brief 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.

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.

Interventions

DRUGPlacebo

Mechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C.

DRUGVitamin C

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
37 Weeks to No maximum
Healthy volunteers
No

Inclusion criteria

* Age more than 37 weeks. * Both sexes. * Neonates with sepsis are diagnosed both clinically and serologically after any surgical intervention.

Exclusion criteria

* Major congenital anomalies and Chromosomal abnormalities. * neonate \<37weeks gestation. * Hypoxic Ischemic Encephalopathy (HIE). * Neuromuscular diseases. * Intraventricular hemorrhage (IV Hge).

Design outcomes

Primary

MeasureTime frameDescription
Duration of mechanical ventilation28 days from the start of ventilationDuration of mechanical ventilation was recorded from start of ventilation till weaning or death.

Secondary

MeasureTime frameDescription
Need for inotropic support28 days from the start of ventilationNeed for inotropic support was recorded.
Mortality28 days from the start of ventilationMortality was recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026