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

NCT06780345 | Completed

• 1 other identifier: 36264PR117/2/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin C; Postoperative; Mechanically Ventilation; Sepsis; Neonate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Need for inotropic support

  28 days from the start of ventilation

• Mortality

  28 days from the start of ventilation

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Vitamin C group

EXPERIMENTAL

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

Interventions

Placebo DRUG

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

Control group

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.

Vitamin C group

Eligibility Criteria

• Age: 37 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 37 weeks.
• Both sexes.
• Neonates with sepsis are diagnosed both clinically and serologically after any surgical intervention.

You may not qualify if:

• Major congenital anomalies and Chromosomal abnormalities.
• neonate \<37weeks gestation.
• Hypoxic Ischemic Encephalopathy (HIE).
• Neuromuscular diseases.
• Intraventricular hemorrhage (IV Hge).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

• Elmesiry AM, Elsheikh MR, Elshimy KM, Abotaleb AM. Role of vitamin C infusion in postoperative mechanically ventilated neonates with sepsis: a randomized controlled trial. Eur J Pediatr. 2025 Nov 29;184(12):806. doi: 10.1007/s00431-025-06625-4.

  PMID: 41315087 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)