Necrotizing Enterocolitis Clinical Trial
Official title:
Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
Verified date | May 2024 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 30, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 37 Weeks |
Eligibility | Inclusion Criteria: - Male and female preterm neonates less than 37 weeks gestational age - Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) . - Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings . - Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool - Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis. - Anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage II NEC Exclusion Criteria: - Term and post term neonates - Neonates with congenital infections - Neonates with major congenital anomalies - Neonates with stage III NEC |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | El Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality rate | record mortality rate in each group during treatment | 2 months | |
Primary | complications and side effects | record any complications or side effects of the treating drugs | 2 months | |
Primary | Inflammatory parameter | Change in serum C-reactive protein at baseline and after 2 months | 2 months | |
Secondary | change in serum high-mobility group box protein 1 (HMGB1) | blood sample will be collected at baseline and after 2 months | 2 months | |
Secondary | change in serum Intestinal fatty acid binding protein (I-FABP). | blood sample will be collected at baseline and after 2 months | 2 months | |
Secondary | change in serum total antioxidant capacity (TAC) | Blood sample will be collected at baseline and after 2 months | 2 months |
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