Clinical trial NCT06422000: Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis
Official title: Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Necrotizing Enterocolitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 75
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.

Detailed description: This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC. Patients are allocated randomly into three groups (each included 25 neonates); group I (traditional therapy group) received antibiotics according to culture and sensitivity results, group II (pentoxifylline group) received antibiotics and IV pentoxifylline at a dose of 30 mg/ Kg given over 6 hours daily until discharge from the unit, and group III (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge. The serum level of high-mobility group box protein 1 (HMGB-1), intestinal fatty acid binding proteins (I-FABP), and total antioxidant capacity (TAC) were measured on admission and at discharge.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality rate
timeFrame: 2 months
measure: complications and side effects
timeFrame: 2 months
measure: Inflammatory parameter
timeFrame: 2 months
Secondary outcomes:
measure: change in serum high-mobility group box protein 1 (HMGB1)
timeFrame: 2 months
measure: change in serum Intestinal fatty acid binding protein (I-FABP).
timeFrame: 2 months
measure: change in serum total antioxidant capacity (TAC)
timeFrame: 2 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbia
Study officials:
affiliation: professor and head of clinical pharmacy department, faculty of Pharmact, Tanta University, Egypt
name: Sahar Hegazy, MD
role: STUDY_DIRECTOR
References: