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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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intervention group

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

Group Type ACTIVE_COMPARATOR

oral n-acetyl cysteine

Intervention Type 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

control group

preterm neonates

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

the control group will receive placebo

Interventions

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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

Intervention Type DRUG

placebo

the control group will receive placebo

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No