Preterm Neonates and Feeding Intolerance, Necrotizing Enterocolitis, Oral N-acetyl Cysteine
Conditions
Keywords
preterm neonates, neonates, feeding intolerance, necrotizing enterocolitis, prematurity, n-acetyl cysteine, oral n-acetyl cysteine
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.
Interventions
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
OTHERplacebo
the control group will receive placebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of necrotizing enterocolitis | 10 days | assess the development of necrotizing enterocolitis |
Countries
Egypt
Outcome results
None listed