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

Necrotizing Enterocolitis Clinical Trial

— Oral NAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06202911
• Other study ID #: Ekram Hassan
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Premature Birth

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of necrotizing enterocolitis	assess the development of necrotizing enterocolitis	10 days

External Links

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