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

Phase 4

Active, not recruiting

• Conditions: Preterm Neonates and Feeding Intolerance; Necrotizing Enterocolitis; Oral N-acetyl Cysteine
• Interventions: Other: placebo; Drug: oral n-acetyl cysteine

• Registration Number: NCT06202911
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• preterm neonates (less than or = 36 weeks gestational age )
• feeding intolerance

Exclusion Criteria

• active gastro-intestinal tract bleeding
• Gastro- intestinal tract surgical problem
• Congenital gastro-intestinal tract anomalies
• evidence of allergy to NAC
• use of prebiotics or probiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	placebo	preterm neonates
intervention group	oral n-acetyl cysteine	preterm neonates with feeding intolerance, pre-Nec., receive the drug

Primary Outcome Measures

Name	Time	Method
incidence of necrotizing enterocolitis	10 days	assess the development of necrotizing enterocolitis

Trial Locations

Locations (1)

Ain Shams university hospitals; 🇪🇬 Cairo, Egypt