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| ID | Type | Description | Link |
|---|---|---|---|
| 01525316 | Registry Identifier | Lactoferrin for prevention of neonatal sepsis |
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| Name | Class |
|---|---|
| Kasr El Aini Hospital | OTHER |
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Oral lactoferrin versus Placebo will be given to preterm neonates
200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | saline is given orally in dose of 2 ml per day for one month |
|
| lacoferrin | Active Comparator | Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin | Drug | lactoferrin is given orally in comparsion to placebp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mortality rate of neonatal sepsis in preterm neonate | Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis | one year |
| Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin | Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia | one year |
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Inclusion Criteria:
All neonates born at Cairo university hospital NICU
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ayman zaher, bachelor | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayman | Asyut | Assuit | 71111 | Egypt |
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| Label | URL |
|---|---|
| lactoferrin | View source |
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lactoferrin improves the mortality rate of neonatal sepsis
all the time
lactoferrin
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2019 | Sep 12, 2019 | SAP_000.pdf |
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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 |
|---|---|
| D007781 | Lactoferrin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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placebo group 100 patient will receive 2 ml saline for one month in comparison with oral lactoferrin for the same period to another 100 patient
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Follow up of the patients with CRP and different cultures.
| Placebos | Drug | placebp is given in 2 ml saline |
|
|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |