Role of vitamin C infusion in postoperative mechanically ventilated neonates with sepsis: a randomized controlled trial.

2025-11-29
European journal of pediatrics 184(12)
- Asmaa Mahmoud Elmesiry
- Mai Rabie Elsheikh
- Khalid Mohamed Elshimy
- Amany Mohamed Abotaleb

PubMed: 41315087
DOI: 10.1007/s00431-025-06625-4

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 50 full-term neonates who required mechanical ventilation and developed confirmed sepsis after surgery
Methods: double-blinded randomized controlled trial; standard sepsis management with placebo or standard protocol with vitamin C infusion, administered as a 0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days
Blinding: Double-blind
Duration: 7 to 10 days

This research investigated the efficacy of intravenous vitamin C administration in septic, mechanically ventilated (MV) full-term neonates following surgical interventions. This double-blinded randomized controlled trial included 50 full-term neonates who required mechanical ventilation and developed confirmed sepsis after surgery. Neonates were randomly assigned to receive either standard sepsis management with placebo (No Vitamin C group) or standard protocol with vitamin C infusion, administered as a 0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days (Vitamin C group). Respiratory rate and peak inspiratory pressure were significantly lower at 24 h, 72 h, and 120 h in the Vitamin C group than in the No Vitamin C group. FiO₂ requirements were significantly reduced at 72 h and 120 h in the Vitamin C group. SpO₂/FiO₂ did not change across groups at baseline and 24 h but were considerably higher in the Vitamin C group at 72 h and 120 h. Duration of MV (4.44 ± 1.23 vs. 5.64 ± 2.2 days, p = 0.021) and inotropic support needs (40% vs. 76%, p = 0.010) were significantly lower in the Vitamin C group. There were no statistically significant differences in mortality rates or the duration of hospitalization, including stays at neonatal intensive care units (NICU) or the hospital.

Conclusion

Vitamin C infusion significantly improved respiratory parameters and reduced the duration of MV and inotropic support requirements in septic neonates following surgery, though it did not significantly affect the NICU or hospital length of stay or mortality.

Trial registration

registered on ClinicalTrials.gov (ID: NCT06780345) (date: 17/1/2025).

What is known

• In neonatal intensive care units (NICU), neonatal sepsis continues to be a major cause of death and morbidity. • Vitamin C has become a possible therapeutic intervention given its many pathways in sepsis control.

What is new

• Vitamin C infusion significantly improved respiratory parameters and reduced the duration of MV and inotropic support requirements in septic neonates following surgery, though it did not significantly affect the NICU or hospital length of stay or mortality.

Research Insights

Vitamin C→Improved Oxygenation Index
SpO2/FiO2 did not change across groups at baseline and 24 h but were considerably higher in the Vitamin C group at 72 h and 120 h.
Effect
Beneficial
Effect size
Moderate
Dose
0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days
Vitamin C→Reduced Duration of Mechanical Ventilation
Duration of MV (4.44 ± 1.23 vs. 5.64 ± 2.2 days, p = 0.021) and inotropic support needs (40% vs. 76%, p = 0.010) were significantly lower in the Vitamin C group.
Effect
Beneficial
Effect size
Moderate
Dose
0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days
Vitamin C→Reduced Inotropic Support Requirement
Duration of MV (4.44 ± 1.23 vs. 5.64 ± 2.2 days, p = 0.021) and inotropic support needs (40% vs. 76%, p = 0.010) were significantly lower in the Vitamin C group.
Effect
Beneficial
Effect size
Moderate
Dose
0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days
Vitamin C→Reduced Oxygen Requirement
FiO₂ requirements were significantly reduced at 72 h and 120 h in the Vitamin C group.
Effect
Beneficial
Effect size
Moderate
Dose
0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days
Vitamin C→Reduced Peak Inspiratory Pressure
Respiratory rate and peak inspiratory pressure were significantly lower at 24 h, 72 h, and 120 h in the Vitamin C group than in the No Vitamin C group.
Effect
Beneficial
Effect size
Moderate
Dose
0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days
Vitamin C→Reduced Respiratory Rate
Respiratory rate and peak inspiratory pressure were significantly lower at 24 h, 72 h, and 120 h in the Vitamin C group than in the No Vitamin C group.
Effect
Beneficial
Effect size
Moderate
Dose
0.5 g/kg loading dose followed by a maintenance dose of 0.5 g/kg/h over 6 h, continued for 7 to 10 days