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

Not Applicable

Completed

• Conditions: Vitamin C; Postoperative; Mechanically Ventilation; Sepsis; Neonate
• Interventions: Drug: Placebo; Drug: Vitamin C

• Registration Number: NCT06780345
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	Mechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C.
Vitamin C group	Vitamin 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.

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	28 days from the start of ventilation	Duration of mechanical ventilation was recorded from start of ventilation till weaning or death.

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days from the start of ventilation	Mortality was recorded.
Need for inotropic support	28 days from the start of ventilation	Need for inotropic support was recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt