NCT06202911

Effect of Oral N-Acetyl Cysteine in Prevention of Necrotizing Enterocolitis in Preterm Neonates With Feeding Intolerance

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

necrotizing enterocolitis is a dangerous disease that may be fatal especially in preterm neonates, the early features of the disease are symptoms of feeding intolerance and interruption of the baby's feeding plan , so prophylactic measures at this stage may help to prevent its progression and its complications. N-acetyl cysteine is an FDA- approved drug and has many uses in different diseases and in different age groups including neonates, it has a mucolytic and anti-inflammatory and anti-oxidant effects that are believed to break the bacterial biofilm which enables it to stick to the intestinal wall and also decrease the intestinal wall inflammation, therefore enhance the intestinal barrier and decrease the chance of bacterial invasion.

Conditions

• Preterm Neonates and Feeding Intolerance
• Necrotizing Enterocolitis
• Oral N-acetyl Cysteine

Interventions

Type	Name	Description
DRUG	oral n-acetyl cysteine	the active participants will receive oral N-acetyl cysteine with dose 20mg/dose every 6 hours for 10 days or until reaching full feeding or resolution of feeding intolerance
OTHER	placebo	the control group will receive placebo

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-03-30
• Completion: 2024-03-30
• First posted: 2024-01-12
• Last updated: 2024-01-12

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study