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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Active Comparator | preterm neonates with feeding intolerance, pre-Nec., receive the drug |
|
| control group | Placebo Comparator | preterm neonates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of necrotizing enterocolitis | assess the development of necrotizing enterocolitis | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university hospitals | Cairo | 1234 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | undefined |
| Label | URL |
|---|---|
| Related Info | View source |
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for patient confidentiality
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| placebo | Other | the control group will receive placebo |
|
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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