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

Ain Shams University

Status and phase: Active, not recruiting; Phase 4

Conditions: Oral N-acetyl Cysteine; Necrotizing Enterocolitis; Preterm Neonates and Feeding Intolerance

Treatments: Other: placebo; Drug: oral n-acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT06202911

Ekram Hassan

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

intervention group

Active Comparator group

Description:

preterm neonates with feeding intolerance, pre-Nec., receive the drug

Treatment:

Drug: oral n-acetyl cysteine

control group

Placebo Comparator group

Description:

preterm neonates

Treatment:

Other: placebo