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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Mechanically Ventilation; Postoperative; Neonate; Vitamin C
• Intervention / Treatment: Drug: Placebo; Drug: Vitamin C

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Mechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C.	Drug: Placebo; Mechanically ventilated neonates will receive the usual protocol of sepsis and a placebo without vitamin C.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	Duration of mechanical ventilation was recorded from start of ventilation till weaning or death.	28 days from the start of ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for inotropic support	Need for inotropic support was recorded.	28 days from the start of ventilation
Mortality	Mortality was recorded.	28 days from the start of ventilation

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 36264PR117/2/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No