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

NCT ID: NCT06780345

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-08-01

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.

Conditions

Vitamin C; Postoperative; Mechanically Ventilation; Sepsis; Neonate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Vitamin C group

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.

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DRUG

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.

Interventions

Placebo

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Amany Mohamed Abotaleb

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR117/2/23

Identifier Type: -

Identifier Source: org_study_id