Skip to main content
OpenTrials
Completed

NCT Number: NCT06780345

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

37 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo

Drug

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

Vitamin C

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.

Primary outcomes

  1. Duration of mechanical ventilation

    Time frame: 28 days from the start of ventilation

    Duration of mechanical ventilation was recorded from start of ventilation till weaning or death.

Secondary outcomes

  1. Need for inotropic support

    Time frame: 28 days from the start of ventilation

    Need for inotropic support was recorded.

  2. Mortality

    Time frame: 28 days from the start of ventilation

    Mortality was recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.