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Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
6. Administration of the iron thrapy:
4-The bottle should Stored in refrigerator for one month after opening of the bottles.
7.Follow up of the patient:
At each follow up visit:
Anthropometric measurements: body weight, length and occipito-frontal circumference will be measured and plotted on the Fenton growth chart for preterm neonates.
Compliance to the drug will be assessed and recorded Gastrointestinal side effect (e.g, vomiting, constipation, abdominal distension) will monitored weekly.
Laboratory investigation will be conducted as previously outlined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care group will receive daily oral ferrous iron | Active Comparator | will receive daily oral ferrous iron |
|
| Daily Liposomal group: will receive daily oral liposomal iron. | Active Comparator | will receive daily oral liposomal iron. |
|
| -Every other day liposomal group: will receive oral liposomal iron every other day. | Active Comparator | will receive oral liposomal iron every other day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily oral ferrous ion | Drug | Will receive oral ferrous iron |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin concentration | Hemoglobin level measured in g/dL to assess the effect of daily versus every-other-day liposomal iron supplementation in preterm neonates. | Baseline before start of oral iron therapy,after that monthly for three months . |
| Serum ferritin level | Serum ferritin concentration measured in ng/mL to assess iron stores | Baseline before starting of oral iron therapy, after that at the end of study after three months. |
| Serum hepcidin level | Serum hepcidin concentration measured in ng/mL. | Before start oral iron therapy,after that daily for three days after start of oral iron therapy. |
| Serum iron level | Serum iron concentration measured in µg/dL. | Baseline before starting of oral iron therapy, after that at the end of study after three months. |
| Total iron-binding capacity (TIBC) | Total iron-binding capacity measured in µg/dL. | Baseline before starting of oral iron therapy, after that at the end of study after three months. |
| Transferrin saturation | Transferrin saturation measured as a percentage (%). | Baseline before starting of oral iron therapy, after that at the end of study after three months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Egypt |
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| Daily oral liposomal iron | Drug | Will receive Daily oral liposomal iron |
|
| Oral liposomal iron every other day | Drug | Will receive Oral liposomal iron every other day |
|