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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06202911
Other study ID # Ekram Hassan
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of necrotizing enterocolitis assess the development of necrotizing enterocolitis 10 days
See also
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Completed NCT02400697 - Placental Transfusion Project for Preterm Infants N/A
Completed NCT01751477 - Infloran® for Prevention of Necrotizing Enterocolitis N/A
Terminated NCT01156480 - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Recruiting NCT01441739 - Intestinal Failure in Necrotising Enterocolitis N/A
Recruiting NCT03869827 - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Recruiting NCT04074824 - A Genome-Wide Association Study for Neonatal Diseases
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting NCT03554278 - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting NCT04541771 - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Phase 2
Not yet recruiting NCT03700957 - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT01745510 - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Phase 1/Phase 2
Completed NCT01735578 - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis N/A
Unknown status NCT01807858 - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants N/A

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