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

Tanta University

Status: Completed

Conditions: Neonate; Vitamin C; Postoperative; Mechanically Ventilation; Sepsis

Treatments: Drug: Placebo; Drug: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT06780345

36264PR117/2/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 37+ weeks old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Vitamin C group

Experimental group

Description:

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.

Treatment:

Drug: Vitamin C