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| ID | Type | Description | Link |
|---|---|---|---|
| R88 | Other Identifier | local institutional research board |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxyfilline arm | Active Comparator | Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics. |
|
| Placebo arm | Placebo Comparator | Intravenous saline as a Placebo 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline (PTX) | Drug | Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal mortality | Mortality before discharge from neonatal intensive care unit | Expected 10 weeks postnatal age |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Duration of hospital admission (days) | Expected average of 8 weeks post natal age |
| Duration of respiratory support | Duration of respiratory support including oxygen, Continuous Positive Airway Pressure, mechanical ventilation(days) |
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Inclusion Criteria:
- Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abd Elazeez AT Shabaan, PhD | Mansoura University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Children Hospital | Al Mansurah | Eldakahlia | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25970116 | Derived | Shabaan AE, Nasef N, Shouman B, Nour I, Mesbah A, Abdel-Hady H. Pentoxifylline therapy for late-onset sepsis in preterm infants: a randomized controlled trial. Pediatr Infect Dis J. 2015 Jun;34(6):e143-8. doi: 10.1097/INF.0000000000000698. |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
| Placebo | Drug | Patients were randomly assigned to receive intravenous normal saline 5 mg/kg/hr for 6 hours on 6 successive days as a placebo in addition to antibiotics. |
|
| Expected 4 to 6 weeks postnatal age |
| Duration of antibiotics use | Duration of treatment of sepsis including meningitis | Expected 3 to 5 weeks postnatal age |
| Chronic lung disease | Need for oxygen by 36 weeks corrected gestational age | By 36 weeks corrected gestational age |
| Necrotising enterocolitis | Bell clinical and radiological criteria | Expected 6 weeks |
| Intraventricular haemorrhage | By cranial ultrasound grading | Expected 2 weeks |
| Periventricular leukomalacia | By cranial ultrasound | Expected 8 weeks |
| Retinopathy of prematurity | Ophthalmologist using Ret-Cam | Expected 8 weeks |
| Serum levels of Tumor necrosis factor-α, C-Reactive protein | 6 days after intervention |
| Adverse effects of Pentoxifylline | Adverse effects of Pentoxifylline such as feeding intolerance, thrombocytopenia and cholestasis. | Up to 10 days after intervention |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |