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The aim of this study is to evaluate the effectiveness of caffeine versus probiotics supplementation as adjuvant therapy for preterm neonates with Bronchopulmonary dysplasia (BPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group (group I) | No Intervention | will include 30 preterm neonates with BPD who will receive traditional therapy of BPD including minimizing exposure to oxygen, ventilation strategies, adequate nutrition and prudent administration of fluids | |
| caffeine group (group II) | Active Comparator | will include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with caffeine by intravenous route at a dose of 20 mg/kg loading dose with a 5-10 mg/kg/day maintenance dose given after 24 h ( Yuan et al., 2022) until discharge from the unit after clinical and laboratory improvement after two months. |
|
| probiotic group (group III) | Active Comparator | will include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with probiotics sachets supplementation orally, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZĀ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement after two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | 5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete blood count | Changes in blood parameters at baseline and after 2 months | 2 months |
| Kidney function test | Changes in creatinine clearance at baseline and after 2 months | 2 months |
| Liver function test | Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months | 2 months |
| Inflammatory parameter | changes in serum C-reactive protein at baseline and after 2 months | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in Serum Tumor necrosis factor alpha (TNF-α) | blood sample will be collected at baseline and after 2 months | 2 months |
| change in serum transforming growth factor (TGF)-β. | blood sample will be collected at baseline and after 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed E Fawzy | Contact | 201117507143 | ahmed150846@pharm.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El Gharbia | Egypt |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Probiotic Formula | Drug | probiotics sachets supplementation orally, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZĀ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement after two months. |
|
| 2 months |
| change in Serum superoxide dismutase (SOD) | blood sample will be collected at baseline and after 2 months | 2 months |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |