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

NCT06202911 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: Ekram Hassan
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

preterm neonates; neonates; feeding intolerance; necrotizing enterocolitis; prematurity; n-acetyl cysteine; oral n-acetyl cysteine

Outcome Measures

Primary Outcomes (1)

• incidence of necrotizing enterocolitis

  assess the development of necrotizing enterocolitis

  10 days

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

Drug: oral n-acetyl cysteine

control group

PLACEBO COMPARATOR

preterm neonates

Other: placebo

Interventions

oral n-acetyl cysteine DRUG

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

intervention group

placebo OTHER

the control group will receive placebo

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, 1234, Egypt

Location

Related Publications (1)

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  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 12, 2024
• Study Start: January 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)